FDA releases October 2013 510(k) approvals
2013-11-05
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510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2013
TOTAL 510(k)s THIS PERIOD 257 TOTAL WITH SUMMARIES 240
TOTAL WITH STATEMENTS 17
DEVICE: ACCESS TOTAL BHCG (5TH IS)
BECKMAN COULTER, INC. 510(k) NO: K130020(TRADITIONAL)
ATTN: GERALDINE L BAGLIEN PHONE NO : 952 368 7645
1000 LAKE HAZELTINE DR. SE DECISION MADE: 01-OCT-13
CHASKA MN 55318 1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K131975(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DRIVE SE DECISION MADE: 02-OCT-13 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K131645(ABBREVIATED) ATTN: NAISHU WANG PHONE NO : 858 513 3888 13200 GREGG ST. SE DECISION MADE: 07-OCT-13 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS C DIFFICILE GDH BIOMERIEUX SA 510(k) NO: K132010(TRADITIONAL) ATTN: CAROLINE KOCH-MATHIAN PHONE NO : 33 478877 032 5 RUE DES AQUEDUCS SE DECISION MADE: 09-OCT-13 CRAPONNE FR 69290 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-ST TIGECYCLINE BIOMERIEUX, INC. 510(k) NO: K131779(TRADITIONAL) ATTN: NATHAN HARDESTY PHONE NO : 314 731 8666 595 ANGLUM RD. SE DECISION MADE: 10-OCT-13 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS OPERATIONS INC 510(k) NO: K131366(TRADITIONAL) ATTN: NATHAN CARRINGTON PHONE NO : 317 521 4793 9115 Hague Rd SE DECISION MADE: 11-OCT-13 Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMDX C.DIFFICILE FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC. 510(k) NO: K132235(TRADITIONAL) ATTN: FRAN WHITE PHONE NO : 978 927 3808 180 CABOT ST SE DECISION MADE: 11-OCT-13 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K132664(TRADITIONAL) ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVE SE DECISION MADE: 16-OCT-13 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM NOVA BIOMEDICAL CORPORATION 510(k) NO: K131013(TRADITIONAL) ATTN: PAUL W MACDONALD, PHD PHONE NO : 781 894 0800 200 Prospect St SE DECISION MADE: 17-OCT-13 WALTHAM MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRSA/SA ELITE MGB, ELITE MGB SOFTWARE ELITECHGROUP EPOCH BIOSCIENCES 510(k) NO: K132468(TRADITIONAL) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5555 21720 23rd Dr SE, Suite 150 SE DECISION MADE: 17-OCT-13 Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) HOLOGIC / GEN-PROBE INCORPORATED 510(k) NO: K132251(TRADITIONAL) ATTN: PHONE NO : 10210 GENETIC CENTER DRIVE SE DECISION MADE: 17-OCT-13 SAN DIEGO CA 92121 4376 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE LUMIQUICK DIAGNOSTICS, INC. 510(k) NO: K130213(TRADITIONAL) ATTN: FENG-YU LEE PHONE NO : 949 951 3046 27001 LA PAZ RD, STE 266B SE DECISION MADE: 18-OCT-13 MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR BIOPHOR DIAGNOSTICS, INC. 510(k) NO: K132096(TRADITIONAL) ATTN: NATHANIEL G BUTLIN PHONE NO : 650 367 4954 1201 DOUGLAS AVE SE DECISION MADE: 18-OCT-13 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX 2200 APLS IGM BIO-RAD LABORATORIES 510(k) NO: K130528(TRADITIONAL) ATTN: JUANG WANG PHONE NO : 510 741 4609 5500 E. 2ND STREET SE DECISION MADE: 21-OCT-13 BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K123713(TRADITIONAL) ATTN: KEVIN J LAWSON PHONE NO : 716 691 0091 60 PINEVIEW DR. SE DECISION MADE: 25-OCT-13 BUFFALO NY 14228 2120 510(k) STATEMENT
DEVICE: S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K132462(TRADITIONAL)
ATTN: ERIKA AMMIRATI PHONE NO : 650 949 2768
575 SHIRLYNN COURT SE DECISION MADE: 28-OCT-13
LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT MONITOR SHENZHEN CREATIVE INDUSTRY CO., LT510(k) NO: K123711(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 12226 WASHINGTON LANE SE DECISION MADE: 01-OCT-13 PARKER AZ 85344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPACT DM LINER CONVERTER MEDACTA INTERNATIONAL 510(k) NO: K131458(TRADITIONAL) ATTN: ADAM GROSS PHONE NO : 805 322 3289 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 01-OCT-13 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRINITY MICROLIFT FACIAL TONING DEVICE CAROL COLE COMPANY 510(k) NO: K131251(TRADITIONAL) ATTN: RAND DAOUD PHONE NO : 760 734 4545 1325 Sycamore Ave Ste A SE DECISION MADE: 01-OCT-13 Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING BIOMET MICROFIXATION 510(k) NO: K132600(SPECIAL) ATTN: ELIZABETH WHEELER PHONE NO : 904 741 4400 1520 TRADEPORT DR. SE DECISION MADE: 02-OCT-13 JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY 510(k) NO: K132693(SPECIAL) ATTN: GREGORY P PAYNE, RAC PHONE NO : 858 795 7890 10865 ROAD TO THE CURE SUITE 200 SE DECISION MADE: 02-OCT-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K130947(TRADITIONAL) ATTN: LEI CHEN PHONE NO : 86 10 88798300 No.9 Shuangyuan Road, Badachu Hi-tSE DECISION MADE: 03-OCT-13 BEIJING CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE SILICONE FOLEY CATHETER GUANGDONG BAIHE MEDICAL TECHNOLOGY510(k) NO: K130908(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 PO BOX 120-119 SE DECISION MADE: 03-OCT-13 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEANSER ROOT CANAL CERKAMED WOJCIECH PAWLOWSKI 510(k) NO: K130180(TRADITIONAL) ATTN: KINGA WIERUCKA PHONE NO : 481 584235 85 KWIATKOWSKIEGO 1 STREET SE DECISION MADE: 03-OCT-13 STALOWA WOLA, PODKARPACIE PL 37510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEDEX DENTMATE TECHNOLOGY CO., LTD. 510(k) NO: K131042(TRADITIONAL) ATTN: CHENG-FENG CHOU PHONE NO : 866 289769 226 8F, No.8-11, Sec.1, Zhongxing RoadSE DECISION MADE: 03-OCT-13 New Taipei City TW 24872 510(k) STATEMENT
DEVICE: EVEREST SPINAL SYSTEM K2M, INC. 510(k) NO: K132361(TRADITIONAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 03-OCT-13 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOTEX POWDER-FREE NITRILE SURGICAL GLOVES SHANGHAI MOTEX HEALTHCARE CO., LTD510(k) NO: K122557(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 862 159 799888 NO. 369, JIASONG ZHONG ROAD HUAXINSE DECISION MADE: 03-OCT-13 SHANGHAI CH 201708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCCLUSION PERFUSION CATHETER ADVANCED CATHETER THERAPIES, INC. 510(k) NO: K130525(TRADITIONAL) ATTN: CHRIS HENZA PHONE NO : 262 842 1257 7401 104TH AVE SE DECISION MADE: 03-OCT-13 KENOSHA WI 53142 510(k) STATEMENT
DEVICE: NEO KNEE SYSTEM PIPELINE ORTHOPEDICS 510(k) NO: K131368(TRADITIONAL) ATTN: TERRY POWELL PHONE NO : 703 562 9800 901 KING STREET, SUITE 200 SE DECISION MADE: 03-OCT-13 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMCAD-UT DETECTION MODEL 2.0 LIN & ASSOCIATES, LLC. 510(k) NO: K122536(TRADITIONAL) ATTN: CHIU S LIN PHONE NO : 301 591 3895 9223 CAMBRIDGE MANOR COURT SE DECISION MADE: 03-OCT-13 POTOMAC MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DICOM VIDEO BAR CODE COMPUTER LTD 510(k) NO: K132183(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 4 8246632 6 SIRENI SE DECISION MADE: 03-OCT-13 HAIFA IS 32972 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, ETHICON ENDO-SURGERY, LLC 510(k) NO: K131435(TRADITIONAL) ATTN: MARICA ARENTZ PHONE NO : 513 337 1066 4545 CREEK ROAD SE DECISION MADE: 03-OCT-13 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANYSCAN-S SPECT IMAGING SYSTEM ABSOLUTE IMAGING SOLUTIONS 510(k) NO: K131625(TRADITIONAL) ATTN: MARK SHINA PHONE NO : 336 643 2000 8205 B&G COURT SE DECISION MADE: 03-OCT-13 STOKESDALE NC 27357 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATUS WARMETTE BLANKET AND DUAL CABINETS NATUS NICOLET IRELAND LTD 510(k) NO: K132110(TRADITIONAL) ATTN: MICHAEL GALVIN PHONE NO : 353 091 647451 IDA BUSINESS PARK SE DECISION MADE: 03-OCT-13 GORT, COUNTY GALWAY EI IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVAFLEX VERTEBRAL BALLOON SYSTEM CAREFUSION 510(k) NO: K131824(TRADITIONAL) ATTN: JOY GREIDANUS PHONE NO : 847 473 7404 75 NORTH FAIRWAY DRIVE SE DECISION MADE: 03-OCT-13 VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICCOLO COMPOSITE NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD. 510(k) NO: K132774(SPECIAL) ATTN: YAEL RUBIN PHONE NO : 972 9 9511511 11 HA’HOSHLIM STREET SE DECISION MADE: 03-OCT-13 HERZELIYA IS 46724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAUTIFIL BULK FLOWABLE SHOFU DENTAL CORPORATION 510(k) NO: K132141(TRADITIONAL) ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DRIVE SE DECISION MADE: 03-OCT-13 SAN MARCOS CA 92078 510(k) STATEMENT
DEVICE: DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST DEROYAL INDUSTRIES, INC. 510(k) NO: K132199(TRADITIONAL) ATTN: COURTNEY RINEHART PHONE NO : 865 362 2122 200 DEBUSK LN. SE DECISION MADE: 03-OCT-13 POWELL TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 AAP IMPLANTATE AG 510(k) NO: K132554(TRADITIONAL) ATTN: CHRISTIAN ZIETSCH PHONE NO : 004 930 75019193 LORENZWEG 5 SE DECISION MADE: 03-OCT-13 BERLIN GM 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED FLOWGATE BALLOON GUIDE CATHETER CONCENTRIC MEDICAL, INC. 510(k) NO: K131492(TRADITIONAL) ATTN: RHODA SANTOS PHONE NO : 510 413 2269 301 E Evelyn Ave SE DECISION MADE: 03-OCT-13 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL 510(k) NO: K132575(SPECIAL) ATTN: AUDREY VION PHONE NO : 33 47 2018787 14 Porte du Grand Lyon SE DECISION MADE: 03-OCT-13 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOZENE MICROSPHERES CELONOVA BIOSCIENCES, INC. 510(k) NO: K132675(SPECIAL) ATTN: NICOLE BARBER PHONE NO : 210 497 6682 18615 Tuscany Stone Ste 100 SE DECISION MADE: 03-OCT-13 San Antonio TX 78258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAUTILUS SPINAL SYSTEM LIFE SPINE, INC 510(k) NO: K132760(SPECIAL) ATTN: RANDY LEWIS PHONE NO : 847 884 6117 2401 W. HASSELL RD SUITE 1535 SE DECISION MADE: 03-OCT-13 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K131673(TRADITIONAL) ATTN: KELLY ANGLIN PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 03-OCT-13 Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOCHEM HT-2000 THERMASOLUTIONS, INC. 510(k) NO: K131583(TRADITIONAL) ATTN: M.W. ANDY ANDERSON PH.D. RAPHONE NO : 952 746 8079 5353 WAYZATA BOULEVARD SUITE 505 SE DECISION MADE: 03-OCT-13 MINNEAPOLIS MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLONGLIDE(R) LUBRICANT PEDIATRIC PHARMACEUTICALS, INC. 510(k) NO: K131617(TRADITIONAL) ATTN: ROBERT M HARRIS PHONE NO : 732 739 2018 2137 ROUTE 35 SE DECISION MADE: 03-OCT-13 HOLMDEL NJ 07733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCKING PLATE SYSTEM BEIJING LIBEIER BIO-ENGINEERING IN510(k) NO: K132642(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 03-OCT-13 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G CAREFUSION 510(k) NO: K131820(TRADITIONAL) ATTN: JOY GREIDANUS PHONE NO : 847 473 7404 75 NORTH FAIRWAY DRIVE SE DECISION MADE: 04-OCT-13 VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISCHEMA VIEW RAPID ISCHEMA VIEW, INC. 510(k) NO: K121447(TRADITIONAL) ATTN: MARC GOODMAN PHONE NO : 949 548 3980 5405 ALTON PARKWAY 5A, #530 SE DECISION MADE: 04-OCT-13 IRVINE CA 92604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNER PEACE KAMABRY, INC., DBA INNER PEACE FOR510(k) NO: K122800(TRADITIONAL) ATTN: YOLANDA SMITH PHONE NO : 888 729 9674 1468 HARWELL HAVE SE DECISION MADE: 04-OCT-13 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFAST CK-MB-II CALIBRATORS MITSUBISHI CHEMICAL MEDIENCE CORPO510(k) NO: K130628(SPECIAL) ATTN: JUDI SMITH PHONE NO : 240 316 3377 2 BETHESDA METRO CENTER SUITE 850 SE DECISION MADE: 04-OCT-13 BETHESDA MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD 510(k) NO: K132861(TRADITIONAL) ATTN: KYEONG-MI PARK PHONE NO : 82 2 21941373 42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 04-OCT-13 SEOUL KS 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES MEDTRONIC, INC. 510(k) NO: K132645(TRADITIONAL) ATTN: CHELSEA PIOSKE PHONE NO : 763 514 9838 7611 NORTHLAND DRIVE SE DECISION MADE: 04-OCT-13 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. 510(k) NO: K132440(SPECIAL) ATTN: KAREN E PETERSON PHONE NO : 763 463 7066 3600 HOLLY LANE NORTH SUITE 40 SE DECISION MADE: 04-OCT-13 PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAXX IBL SYSTEM SPINE WAVE, INC. 510(k) NO: K132719(SPECIAL) ATTN: ROAIDA RIZKALLAH PHONE NO : 203 944 9494 3 ENTERPRISE DR. SUITE 210 SE DECISION MADE: 04-OCT-13 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED 510(k) NO: K132768(SPECIAL) ATTN: TOKI WU PHONE NO : 86 755 26722890 YIZHE BLDG, YUQUAN ROAD SE DECISION MADE: 04-OCT-13 SHENZHEN, GUANGDONG CH 518051 P510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER ARTERIOCYTE MEDICAL SYSTEMS, INC. 510(k) NO: K132905(TRADITIONAL) ATTN: ANN CHAREST PHONE NO : 508 497 8964 45 SOUTH STREET SE DECISION MADE: 04-OCT-13 HOPKINTON MA 01748 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: MICROPLEX COIL SYSTEM (MCS) MICROVENTION, INC. 510(k) NO: K131948(SPECIAL) ATTN: LARAINE PANGELINA PHONE NO : 714 247 8150 1311 VALENCIA AVE SE DECISION MADE: 04-OCT-13 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT ARTHROCARE CORP. 510(k) NO: K131709(SPECIAL) ATTN: ASHLEY DAWSON PHONE NO : 512 358 5773 7000 W.WILLIAM CANNON DRIVE BUILDISE DECISION MADE: 04-OCT-13 AUSTIN TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAHEAT PATIENT WARMING SYSTEM VITAHEAT MEDICAL, LLC 510(k) NO: K132454(TRADITIONAL) ATTN: JACK SLOVICK PHONE NO : 763 639 0238 1585 BEVERLY DR. #121 SE DECISION MADE: 04-OCT-13 AURORA IL 60502 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: SMARTSITE VIALSHIELD YUKON MEDICAL, LLC 510(k) NO: K132863(TRADITIONAL) ATTN: PHONE NO : 2200 Gateway Centre Blvd Ste 208 SE DECISION MADE: 04-OCT-13 Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: KYMCO EQ20C SCOOTER KWANG YANG MOTOR CO., LTD. 510(k) NO: K130940(TRADITIONAL) ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396 16F-2 (16A), NO. 462, SEC. 2, CHONSE DECISION MADE: 07-OCT-13 BEITUN DIST., TAICHUNG TW 406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET COOK, INC. 510(k) NO: K131201(TRADITIONAL) ATTN: ERUM B NASIR PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 07-OCT-13 Blmgtn IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISI MOBILE MONITORING SYSTEM SOTERA WIRELESS, INC 510(k) NO: K130709(TRADITIONAL) ATTN: EBEN GORDON PHONE NO : 858 373 4841 9444 WAPLES STREET SE DECISION MADE: 07-OCT-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRELLIS COLLAGEN RIBBON WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K131143(TRADITIONAL) ATTN: SARAH HOLTGREWE PHONE NO : 901 867 4476 5677 AIRLINE RD. SE DECISION MADE: 07-OCT-13 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM PIVOT MEDICAL INC. 510(k) NO: K131769(TRADITIONAL) ATTN: JON COOK PHONE NO : 408 774 1452 247 HUMBOLDT CT SE DECISION MADE: 07-OCT-13 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES THERMOMEDICS INC. 510(k) NO: K131771(TRADITIONAL) ATTN: PAUL LIU PHONE NO : 886 26625 8188X6134 6F, NO. 127, WUGONG 2ND RD., WUGU SE DECISION MADE: 07-OCT-13 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESOFLIP BALLOON DILATION CATHETER CROSPON, LTD. 510(k) NO: K132337(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 07-OCT-13 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEM-6221 OMRON HEALTHCARE, INC. 510(k) NO: K131749(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 07-OCT-13 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V8 SP NORMAL CONTROL, ABNORMAL CONTROL HELENA LABORATORIES 510(k) NO: K131479(TRADITIONAL) ATTN: JUSTIN PADIA PHONE NO : 409 842 3714 1530 LINDBERGH DR. SE DECISION MADE: 07-OCT-13 BEAUMONT TX 77704 510(k) STATEMENT
DEVICE: ESTECH COBRA(R) GENESIS BIPOLAR CLAMP ESTECH, INC. 510(k) NO: K133017(SPECIAL) ATTN: TAMER IBRAHIM PHONE NO : 925 543 2110 2603 CAMINO RAMON, STE 100 SE DECISION MADE: 07-OCT-13 SAN RAMON CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS PIXIUM 4343RC PHILIPS MEDICAL SYSTEMS DMC GMBH 510(k) NO: K131483(TRADITIONAL) ATTN: JENNIFER CARTLEDGE PHONE NO : 864 500 0097 409 WOODRIDGE DR. SE DECISION MADE: 07-OCT-13 SENECA SC 29672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES UNIMED SURGICAL PRODUCTS, INC. 510(k) NO: K132224(TRADITIONAL) ATTN: LEE ALEXANDER PHONE NO : 727 546 1900 10401 BELCHER RD. SE DECISION MADE: 08-OCT-13 LARGO FL 33777 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPREHENSIVE REVERSE SHOULDER – TITANIUM GLENOSPHERE BIOMET MANUFACTURING CORP. 510(k) NO: K131353(TRADITIONAL) ATTN: PATRICIA S BERES PHONE NO : 574 267 6639 56 EAST BELL DRIVE SE DECISION MADE: 08-OCT-13 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX KNEE MODULAR TIBIA SYSTEM OMNI LIFE SCIENCE, INC. 510(k) NO: K131472(TRADITIONAL) ATTN: BRANDON MOLINA PHONE NO : 774 226 1815 50 O’CONNELL WAY SE DECISION MADE: 08-OCT-13 EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R7 CEFLA S.C. 510(k) NO: K130834(TRADITIONAL) ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 2630 110 E. GRANADA BLVD. SUITE 207 SE DECISION MADE: 08-OCT-13 ORMOND BEACH FL 32176 510(k) STATEMENT
DEVICE: WECK EFX ENDO FASCIAL CLOSURE SYSTEM TELEFLEX MEDICAL, INC. 510(k) NO: K132362(TRADITIONAL) ATTN: NATALIE HICHAK PHONE NO : 919 361 4071 2917 WECK DR. SE DECISION MADE: 08-OCT-13 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM SYNTHES (USA) PRODUCTS LLC 510(k) NO: K131186(TRADITIONAL) ATTN: REBECCA G REITER PHONE NO : 610 719 1268 1301 GOSHEN PKWY. SE DECISION MADE: 08-OCT-13 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIODESIGN CRANIAL BASE DURAL GRAFT COOK BIOTECH, INC. 510(k) NO: K131015(TRADITIONAL) ATTN: MARY A FADERAN PHONE NO : 765 497 3355 1425 INNOVATION PLACE SE DECISION MADE: 08-OCT-13 West Lafayette IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDDUSA BIPOLAR SYSTEM ELLIQUENCE LLC 510(k) NO: K130110(TRADITIONAL) ATTN: OSCAR R PAREDES PHONE NO : 516 277 9024 2455 Grand Avenue SE DECISION MADE: 08-OCT-13 Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INMODE WMBODY DEVICE INMODE MD LTD. 510(k) NO: K131362(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 976700 02 20 HATA’AS STR., SUITE 102 SE DECISION MADE: 08-OCT-13 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRONTOSAN WOUND GEL X B. BRAUN MEDICAL, INC. 510(k) NO: K130857(TRADITIONAL) ATTN: NANCY SKOCYPEC PHONE NO : 610 266 0500 901 MARCON BLVD. SE DECISION MADE: 08-OCT-13 ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS MAQUET CARDIOPULMONARY AG 510(k) NO: K132829(SPECIAL) ATTN: WHITNEY TORNING PHONE NO : 973 709 7994 45 BARBOUR POND DRIVE SE DECISION MADE: 08-OCT-13 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEL-GE CARE INNOVATIONS QUIETCARE INTEL-GE CARE INNOVATIONS LLC 510(k) NO: K131585(TRADITIONAL) ATTN: MAUREEN GLYNN PHONE NO : 916 847 7794 1721 DOUGLAS BLVD SUITE 100 SE DECISION MADE: 08-OCT-13 ROSEVILLE CA 95661 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS BAXTER HEALTHCARE CORP. 510(k) NO: K132734(SPECIAL) ATTN: GARY CHUMBIMUNE PHONE NO : 224 270 3312 32650 N WILSON RD. SE DECISION MADE: 08-OCT-13 ROUND LAKE IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K132471(SPECIAL) ATTN: SOWMYA SHETTY PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 08-OCT-13 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) LIFE SPINE, INC 510(k) NO: K132589(SPECIAL) ATTN: RANDY LEWIS PHONE NO : 847 884 6117 2401 W. HASSELL RD SUITE 1535 SE DECISION MADE: 08-OCT-13 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NERIA SOFT 90 INFUSION SET UNOMEDICAL A/S 510(k) NO: K132142(TRADITIONAL) ATTN: DEIRDRE BARROW PHONE NO : 440 170952 5256 UNIT B9, TAYLORS COURT, PARKGATE SE DECISION MADE: 08-OCT-13 ROTHERHAM, SOUTH YORKSHIRE UK S510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESOPHAGEAL TTS STENT TAEWOONG MEDICAL CO., LTD 510(k) NO: K123205(TRADITIONAL) ATTN: CALLEY HERZOG PHONE NO : 720 883 3633 13417 QUIVAS ST SE DECISION MADE: 09-OCT-13 WESTMINSTER CO 80234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPREHENSIVE CONVERTIBLE GLENOID BIOMET MANUFACTURING, INC. 510(k) NO: K130390(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574 267 6639 56 EAST BELL DR. SE DECISION MADE: 09-OCT-13 WARSAW IN 46580 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROLLINS 7 OXYGEN MASK ROLLINS MEDICAL SOLUTIONS, INC. 510(k) NO: K130379(TRADITIONAL) ATTN: E. J SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE. SE DECISION MADE: 09-OCT-13 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER SURGICAL INSTRUMENT ENGINEERING AG510(k) NO: K131207(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 33 GOLDEN EAGLE LANE SE DECISION MADE: 09-OCT-13 LITTLETON CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW BIOMET 510(k) NO: K132704(TRADITIONAL) ATTN: SUZANA OTANO PHONE NO : 305 269 6386 56 EAST BELL DR. P.O BOX 587 SE DECISION MADE: 09-OCT-13 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY ODM TOPCON MEDICAL SYSTEMS, INC. 510(k) NO: K132667(TRADITIONAL) ATTN: MAUREEN O’CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 09-OCT-13 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS PLAYTEX MANUFACTURING INC. 510(k) NO: K132819(SPECIAL) ATTN: PUSHPA RAO PHONE NO : 201 785 8070 75 COMMERCE DR. SE DECISION MADE: 09-OCT-13 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEZANNE II INTERBODY FUSION SYSTEM ACCEL SPINE 510(k) NO: K131981(TRADITIONAL) ATTN: LISA PETERSON PHONE NO : 512 507 0746 14901 QUORUM DR. STE. 125 SE DECISION MADE: 09-OCT-13 DALLAS TX 75254 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AU BICARBONATE REAGENT BECKMAN COULTER IRELAND INC 510(k) NO: K131546(TRADITIONAL) ATTN: DAVID G DAVIS PHONE NO : 469 236 8180 250 S. KRAEMER BLVD. E1.SE.01 SE DECISION MADE: 09-OCT-13 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAMILTON-G5 HAMILTON MEDICAL AG 510(k) NO: K131774(TRADITIONAL) ATTN: RALPH AGUILA PHONE NO : 41 91 6606845 VIA CRUSCH 8 SE DECISION MADE: 09-OCT-13 BONADUZ, GRISONS SZ 7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARUS CONNECT ACUMED LLC 510(k) NO: K131636(TRADITIONAL) ATTN: BRITTANY CUNNINGHAM PHONE NO : 503 207 1467 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 10-OCT-13 HILLSBORO OR 97124 9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K131662(ABBREVIATED) ATTN: GARO MIMARYAN PHONE NO : 914 524 3270 511 BENEDICT AVE. SE DECISION MADE: 10-OCT-13 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEERSCOPE SYSTEM ENDOCHOICE, INC. 510(k) NO: K131422(TRADITIONAL) ATTN: TAMAR FUERST PHONE NO : 972 4 6327731 2 HATOCHEN ST., BUSINESS AND INDUSSE DECISION MADE: 10-OCT-13 CAESAREA IS 38900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 TIBIAL NAILING SYSTEM STRYKER TRAUMA AG 510(k) NO: K131365(TRADITIONAL) ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 10-OCT-13 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA SMITH & NEPHEW, INC. 510(k) NO: K130728(TRADITIONAL) ATTN: SAMEER MANSOUR PHONE NO : 901 399 5579 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 10-OCT-13 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INERTIA MIS PEDICLE SCREW SYSTEM NEXXT SPINE LLC 510(k) NO: K132412(SPECIAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 10-OCT-13 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDYS LIF CAGES CLARIANCE 510(k) NO: K131178(TRADITIONAL) ATTN: JANICE M HOGAN, ESQ. PHONE NO : 267 675 4611 1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 10-OCT-13 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANET SPINE SYSTEM IMPLANET S.A. 510(k) NO: K132303(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST. 29TH FLOOR SE DECISION MADE: 10-OCT-13 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE CONNECTED HEALTH SYSTEM NXSTAGE MEDICAL, INC. 510(k) NO: K131739(TRADITIONAL) ATTN: MARY LOU STROUMBOS PHONE NO : 978 687 4872 350 Merrimack St SE DECISION MADE: 10-OCT-13 LAWRENCE MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOX(R) DELTA CERAMIC HEADS BIOMET, INC. 510(k) NO: K131684(TRADITIONAL) ATTN: BECKY EARL PHONE NO : 574 372 1518 56 EAST BELL DR. BOX 587 SE DECISION MADE: 10-OCT-13 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTEX MEDICAL CARDIOQ-EDM+ DELTEX MEDICAL LIMITED 510(k) NO: K132139(TRADITIONAL) ATTN: RONALD S WARREN PHONE NO : 858 753 1961 11440 W. BERNARDO CT. SUITE 300 SE DECISION MADE: 10-OCT-13 SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL 510(k) NO: K132482(SPECIAL) ATTN: REBECCA K PINE PHONE NO : 760 809 5178 18 Technology Dr Ste 169 SE DECISION MADE: 10-OCT-13 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3B LASER NEEDLE LIVETEC GMBH 510(k) NO: K131797(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 33 GOLDEN EAGLE LANE SE DECISION MADE: 10-OCT-13 LITTLETON CO 80127 510(k) STATEMENT
DEVICE: THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN MEDICAL PRODUCTS, LLC 510(k) NO: K131023(TRADITIONAL) ATTN: DAVID MCGILL PHONE NO : 317 432 5114 7437 OAKLANDON RD. SE DECISION MADE: 11-OCT-13 INDIANAPOLIS IN 46236 510(k) STATEMENT
DEVICE: BASIC AND DOMINANT FLEX SUCTION PUMPS MEDELA AG 510(k) NO: K130123(TRADITIONAL) ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023 W324S3649 COUNTY ROAD E SE DECISION MADE: 11-OCT-13 DOUSMAN WI 53118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON S2000 AND S3000 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130881(TRADITIONAL) ATTN: SHELLY PEARCE PHONE NO : 650 694 5988 1230 SHOREBIRD WAY SE DECISION MADE: 11-OCT-13 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PPA/BT-RB STETHOSCOPE RNK PRODUCTS, INC. 510(k) NO: K132405(TRADITIONAL) ATTN: CHARLES R ABBRUSCATO PHONE NO : 321 610 3980 8247 Devereux Dr Ste 101 SE DECISION MADE: 11-OCT-13 Melbourne FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDICOR CPAM WITH SDB (SINGLE SENSOR) INOVISE MEDICAL, INC. 510(k) NO: K130660(TRADITIONAL) ATTN: EARL ANDERSON PHONE NO : 503 431 3800 8770 SW NIMBUS AVE. SUITE D SE DECISION MADE: 11-OCT-13 Beaverton OR 97008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVERSE MEDICAL MICROCATHETER REVERSE MEDICAL CORPORATION 510(k) NO: K130858(TRADITIONAL) ATTN: JEFFREY VALKO PHONE NO : 949 215 0660 13700 ALTON PARKWAY SUITE 167 SE DECISION MADE: 11-OCT-13 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED CONCENTRIC MICROCATHETER CONCENTRIC MEDICAL, INC. 510(k) NO: K131437(TRADITIONAL) ATTN: CHRISTINA ROWE PHONE NO : 510 413 2486 301 E. EVELYN AVE. SE DECISION MADE: 11-OCT-13 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLASSIC INTERMITTENT CATHETER FLEXICARE MEDICAL LTD. 510(k) NO: K132619(TRADITIONAL) ATTN: CHRISTOPHER WATKINS PHONE NO : 44 1443 474560 CYNON VALLEY BUSINESS PARK MOUTAINSE DECISION MADE: 11-OCT-13 MID GLAMORGAN UK CF45 4ER 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: MTM(R) CLEAR ALIGNER DENTSPLY INTERNATIONAL, INC. 510(k) NO: K132145(TRADITIONAL) ATTN: HELEN LEWIS PHONE NO : 717 487 1332 SUSQUEHANNA COMMERCE CTR., 221 W. SE DECISION MADE: 11-OCT-13 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCP-USB STETHOSCOPE RNK PRODUCTS, INC. 510(k) NO: K132560(TRADITIONAL) ATTN: CHARLES R ABBRUSCATO PHONE NO : 621 610 3980 8247 Devereux Dr Ste 101 SE DECISION MADE: 11-OCT-13 Melbourne FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGH ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K131807(TRADITIONAL) ATTN: PETER J CORONADO PHONE NO : 650 424 6320 3100 HANSEN WAY SE DECISION MADE: 11-OCT-13 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES INC. 510(k) NO: K131677(TRADITIONAL) ATTN: JOHN MCINTYRE PHONE NO : 949 837 3600 13900 ALTON PKWY STE 123 SE DECISION MADE: 11-OCT-13 IRVINE CA 92618 0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET COOK INCORPORATED 510(k) NO: K132885(SPECIAL) ATTN: SEAN SPENCE PHONE NO : 812 335 3575 750 DANIELS WAY SE DECISION MADE: 11-OCT-13 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KATANA ZIRCONIA KURARAY NORITAKE DENTAL INC. 510(k) NO: K131534(TRADITIONAL) ATTN: IVAN WASSERMAN PHONE NO : 202 585 6529 700 12TH ST SW SUITE 100 SE DECISION MADE: 11-OCT-13 WASHINGTON DC 20005 510(k) STATEMENT
DEVICE: BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA ORTHO DEVELOPMENT CORP. 510(k) NO: K131337(TRADITIONAL) ATTN: TOM HAUETER PHONE NO : 801 553 9991 12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 11-OCT-13 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K131908(TRADITIONAL) ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479 920 WINTER STREET SE DECISION MADE: 11-OCT-13 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEATTLE – PAP SEATTLE CHILDRENS HOSPITAL 510(k) NO: K131502(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 1900 NINTH AVENUE SE DECISION MADE: 11-OCT-13 SEATTLE WA 98101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS EXACTECH, INC. 510(k) NO: K132161(TRADITIONAL) ATTN: PATRICK HUGHES PHONE NO : 352 327 4762 2320 N.W. 66TH CT. SE DECISION MADE: 11-OCT-13 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-CONTACT INFRARED THERMOMETER JINXINBAO ELECTRONIC CO.,LTD 510(k) NO: K130231(ABBREVIATED) ATTN: HELEN NAN PHONE NO : 086 577886 06182 ROOM 404, BLDG 7, JINHUICHANG HOMESE DECISION MADE: 15-OCT-13 WENZHOU, ZHEJIANG CH 325000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) BRONCUS MEDICAL INC 510(k) NO: K131234(TRADITIONAL) ATTN: MAHTAB FATEMI PHONE NO : 650 428 1600 1400 N. Shoreline Blvd., Bldg A, SSE DECISION MADE: 15-OCT-13 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: ENDOCHOICE HOT BIOPSY FORCEPS ENDOCHOICE, INC. 510(k) NO: K131991(TRADITIONAL) ATTN: DANIEL HOEFER PHONE NO : 678 708 4743 11810 WILLS ROAD SE DECISION MADE: 15-OCT-13 ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTICHEM U TECHNO-PATH MANUFACTURING LTD. 510(k) NO: K131993(ABBREVIATED) ATTN: STEPHANIE G GARTH PHONE NO : 469 230 0959 325 BIG ELM ST. SE DECISION MADE: 15-OCT-13 HIGHLAND VILLAGE TX 75077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NASAL COMFORT FREEDOM LAKEVIEW SLEEP CENTER 510(k) NO: K130686(TRADITIONAL) ATTN: ANDY BLACK PHONE NO : 847 620 7990 400 NORTH RAND RD SE DECISION MADE: 16-OCT-13 NORTH BARRINGTON IL 60010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROW FUSION NLT SPINE LTD 510(k) NO: K130254(TRADITIONAL) ATTN: JONATHAN KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH STREET NW SE DECISION MADE: 16-OCT-13 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OVATION 10/12 HIP STEM ORTHO DEVELOPMENT CORP. 510(k) NO: K131022(TRADITIONAL) ATTN: TOM HAUETER PHONE NO : 801 553 9991 12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 16-OCT-13 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS TORNIER SAS 510(k) NO: K131231(TRADITIONAL) ATTN: SEVERINE BONNETON PHONE NO : 003 347 6613500 161 RUE LAVOISIER SE DECISION MADE: 16-OCT-13 MONTBONNOT SAINT MARTIN FR 3833510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE SUCTION COAGULATOR MEDLINE INDUSTRIES, INC. 510(k) NO: K122949(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 16-OCT-13 MUNDELEIN IL 60060 510(k) STATEMENT
DEVICE: PEDIATRIC FOLDING WHEELCHAIR COLUMBIA MEDICAL MFG, LLC 510(k) NO: K130644(ABBREVIATED) ATTN: GARY WERSCHMIDT PHONE NO : 562 282 0244 11724 WILLAKE ST SE DECISION MADE: 16-OCT-13 SANTA FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K131047(TRADITIONAL) ATTN: LEI CHEN PHONE NO : 86 10 88794630 NO. 9 SHUANGYUAN ROAD, BADACHU HI-SE DECISION MADE: 16-OCT-13 SHIJINGSHAN DISTRICT, BEIJING C510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAEMAR CARDIOKEY HOLTER RECORDER BRAEMAR MANUFACTURING LLC 510(k) NO: K130294(SPECIAL) ATTN: KENT SAYLER PHONE NO : 619 243 7500 750 B. STREET, STUITE 1400 SE DECISION MADE: 16-OCT-13 SAN DIEGO CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A.I.M. SUTURE ANCHOR ANCHOR INNOVATION MEDICAL, INC. 510(k) NO: K132461(TRADITIONAL) ATTN: HOWARD L SCHRAYER PHONE NO : 5410 EDSON LANE SUITE 308 SE DECISION MADE: 16-OCT-13 ROCKVILLE MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANTAGE TITAN 3T TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K132160(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 730 5000 2441 MICHELLE DRIVE SE DECISION MADE: 16-OCT-13 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: .DECIMAL PROTON APERTURE .DECIMAL, INC. 510(k) NO: K132236(TRADITIONAL) ATTN: KIMBERLY RUPP PHONE NO : 407 330 3300 121 CENTRAL PARK PLACE SE DECISION MADE: 16-OCT-13 SANFORD FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFUSE IMPLANT SYSTEM SI-BONE, INC. 510(k) NO: K131405(TRADITIONAL) ATTN: CINDY DOMECUS PHONE NO : 650 343 4813 1171 BARROILHET DR SE DECISION MADE: 16-OCT-13 HILLSBOROUGH CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMOOTH OR THREADED METALLIC BONE FASTENER BIOMEDICAL ENT., INC. 510(k) NO: K131640(TRADITIONAL) ATTN: JOE SOWARD PHONE NO : 210 677 0354 14785 OMICRON DR., SUITE 205 SE DECISION MADE: 16-OCT-13 SAN ANTONIO TX 78245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF LEGACY MEDICAL, INC. 510(k) NO: K130942(TRADITIONAL) ATTN: DEB ROBERTSON PHONE NO : 952 322 7240 9039 Horizon Dr SE DECISION MADE: 17-OCT-13 Shakopee MN 55379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVATION
AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K131167(TRADITIONAL)
ATTN: JULIE T WING PHONE NO : 610 984 9147
3773 CORPORATE PARKWAY SE DECISION MADE: 17-OCT-13
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TVC IMAGING SYSTEM, TVC INSIGHT CATHETER INFRAREDX, INC. 510(k) NO: K130719(TRADITIONAL) ATTN: STEVE CHARTIER PHONE NO : 781 345 9593 34 THIRD AVE SE DECISION MADE: 17-OCT-13 BURLINGTON MA 01803 510(k) STATEMENT
DEVICE: INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K131872(SPECIAL) ATTN: MARKUS STACHA PHONE NO : 49 7031 4632840 HEWLETT-PACKARD STR.2 SE DECISION MADE: 17-OCT-13 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUE SPINAL FIXATION SYSTEM INNOVATIVE SURGICAL DESIGNS 510(k) NO: K130958(TRADITIONAL) ATTN: ED MORRIS PHONE NO : 812 774 9297 2660 E. 2ND STREET #10 SE DECISION MADE: 17-OCT-13 BLOOMINGTON IN 47401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NBM-200MP ORSENSE LTD 510(k) NO: K124041(TRADITIONAL) ATTN: MARK A HELLER PHONE NO : 202 346 4107 901 NEW YORK AVE, N.W. SE DECISION MADE: 17-OCT-13 WASHINGTON DC 20001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOROOT RCS NOVOCOL, INC. 510(k) NO: K130601(ABBREVIATED) ATTN: CORA BRACHO-TROCONIS PHONE NO : 303 665 7535 416 SOUTH TAYLOR AVE. SE DECISION MADE: 17-OCT-13 LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIGUIDE DELIVERY SYSTEM RESPICARDIA 510(k) NO: K130378(TRADITIONAL) ATTN: BONNIE LABOSKY PHONE NO : 952 540 4470 12400 WHITEWATER DRIVE SUITE 150 SE DECISION MADE: 17-OCT-13 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE AAP IMPLANTATE AG 510(k) NO: K131459(TRADITIONAL) ATTN: CHRISTIAN ZIETSCH PHONE NO : 49 307501 9193 LORENZWEG 5 SE DECISION MADE: 17-OCT-13 BERLIN GM 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE ETHICON ENDO-SURGERY, LLC 510(k) NO: K132612(TRADITIONAL) ATTN: BRIAN GODWIN PHONE NO : 513 337 3623 4545 CREEK ROAD SE DECISION MADE: 17-OCT-13 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSCEND AUTO SOMNETICS INTERNATIONAL, INC. 510(k) NO: K132127(TRADITIONAL) ATTN: MELINDA SWANSON PHONE NO : 651 621 1800 33 5TH AVE NW, STE 500 SE DECISION MADE: 17-OCT-13 NEW BRIGHTON MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SITE-RITE VISION II ULTRASOUND SYSTEM C.R. BARD, INC. 510(k) NO: K132942(SPECIAL) ATTN: KERRIE HAMBLIN PHONE NO : 801 522 4909 605 NORTH 5600 WEST SE DECISION MADE: 17-OCT-13 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K132636(TRADITIONAL) ATTN: KATHLEEN SOLOMON PHONE NO : 978 749 1605 150 MINUTEMAN RD. SE DECISION MADE: 17-OCT-13 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL NEURO 3 SYSTEM STRYKER 510(k) NO: K131775(TRADITIONAL) ATTN: MANISH PATEL PHONE NO : 269 388 4271 750 TRADE CENTRE WAY STE 200 SE DECISION MADE: 17-OCT-13 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K132430(TRADITIONAL) ATTN: CHRISTOPHER DACHEL PHONE NO : 763 494 2718 ONE SCIMED PLACE SE DECISION MADE: 17-OCT-13 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAPPHIRE INFUSION PUMP Q CORE MEDICAL LTD 510(k) NO: K123049(TRADITIONAL) ATTN: RHONA SHANKER PHONE NO : 301 251 9570 12154 DARNESTOWN ROAD #236 SE DECISION MADE: 17-OCT-13 GAITHERBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMNOLYZER 24X7 RESPIRONICS, INC. 510(k) NO: K131994(TRADITIONAL) ATTN: DANIELA AIZPITARTE PHONE NO : 724 387 7954 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 17-OCT-13 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGENET 5 PC SOFTWARE SYSTEM TOPCON MEDICAL SYSTEMS, INC. 510(k) NO: K132438(TRADITIONAL) ATTN: MAUREEN O’CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 17-OCT-13 NORTH READING MA 01864 510(k) STATEMENT
DEVICE: GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION GLOOKO, INC. 510(k) NO: K132272(SPECIAL) ATTN: SHILPA MYDUR PHONE NO : 650 720 5310 170A UNIVERSITY AVENUE SE DECISION MADE: 17-OCT-13 PALO ALTO CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS 510(k) NO: K130684(TRADITIONAL) ATTN: NANCY BURKE PHONE NO : 425 487 7000 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 18-OCT-13 BOTHELL WA 98041 3003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASA ORAL APPLIANCES AMERICAN SLEEP ASSOCIATION 510(k) NO: K130504(TRADITIONAL) ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457 PO BOX 566 SE DECISION MADE: 18-OCT-13 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS BIOMET SPORTS MEDICINE 510(k) NO: K122437(TRADITIONAL) ATTN: ELIZABETH WRAY PHONE NO : 574 371 1176 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 18-OCT-13 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANIAL MAP NEURO STRYKER CORPORATE 510(k) NO: K131214(TRADITIONAL) ATTN: LILIAN ECKERT PHONE NO : 49 761 4512117 BOETZINGER STR. 41 SE DECISION MADE: 18-OCT-13 FREIBURG, BADEN-WUERTTEMBERG GM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY ROCHE DIAGNOSTICS 510(k) NO: K132571(TRADITIONAL) ATTN: KELLI TURNER PHONE NO : 317 521 4515 9115 HAGUE ROAD SE DECISION MADE: 18-OCT-13 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS BOSTON SCIENTIFIC CORP. 510(k) NO: K132947(SPECIAL) ATTN: MAUREEN SUNDEEN PHONE NO : 763 494 2903 ONE SCIMED PLACE SE DECISION MADE: 18-OCT-13 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIFUNCTIONAL SERIES BEIJING HONKON TECHNOLOGIES CO., L510(k) NO: K131859(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 18-OCT-13 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK ETHICON ENDO-SURGERY, LLC 510(k) NO: K131663(TRADITIONAL) ATTN: CHRISTINA CANTER PHONE NO : 513 337 7321 4545 CREEK ROAD SE DECISION MADE: 18-OCT-13 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMSTAR AUTO A-FLEX HT RESPIRONICS, INC. 510(k) NO: K131982(SPECIAL) ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 18-OCT-13 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LENSTEC LC INJECTION SYSTEM LENSTEC, INC. 510(k) NO: K122848(TRADITIONAL) ATTN: JIMMY CHACKO PHONE NO : 727 571 2272 1765 Commerce Ave N SE DECISION MADE: 18-OCT-13 Saint Petersburg FL 33716 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: PROVOX VEGA PUNCTURE SET ATOS MEDICAL AB 510(k) NO: K131947(TRADITIONAL) ATTN: FERENC DAHNER PHONE NO : 46 415198 00 KRAFTGATAN 8 SE DECISION MADE: 18-OCT-13 HORBY SW SE-24222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER OLYMPUS SURGICAL TECHNOLOGIES AMER510(k) NO: K132181(TRADITIONAL) ATTN: NEIL KELLY PHONE NO : 908 804 2600 136 TURNPIKE ROAD SE DECISION MADE: 21-OCT-13 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEO DENTA ZIRCONIA NEO GROUP LIMITED 510(k) NO: K130198(TRADITIONAL) ATTN: MIKE ADAMS PHONE NO : 852 235 69700 ROOM Q1D G/F, KAISER EST 3RD PHASESE DECISION MADE: 21-OCT-13 HUNG HOM, KOWLOON HK HK 852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM PURITAN MEDICAL PRODUCTS LLC 510(k) NO: K131630(TRADITIONAL) ATTN: MEHDI KARAMCHI PHONE NO : 207 876 3311 31 SCHOOL STREET P.O. BOX 149 SE DECISION MADE: 21-OCT-13 GUILFORD ME 04443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWIFT AIR RESMED LTD. 510(k) NO: K132013(TRADITIONAL) ATTN: JIM CASSI PHONE NO : 858 836 6081 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 21-OCT-13 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LESSER METATARSAL HEAD IMPLANT SYSTEM SOLANA SURGICAL, LLC 510(k) NO: K131187(TRADITIONAL) ATTN: JOE CLIFT PHONE NO : 901 818 1860 6363 POPLAR AVENUE SUITE 312 SE DECISION MADE: 22-OCT-13 MEMPHIS TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIFLUX SYSTEM 6000 PERIMED AB 510(k) NO: K131253(ABBREVIATED) ATTN: MARIA LILJEVRET PHONE NO : 46 8 58011990 DATAVAGEN 9 A SE DECISION MADE: 22-OCT-13 JARFALLA SE 17543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANFAC BONE MARROW ASPIRATION NEEDLE RANFAC CORP. 510(k) NO: K131157(TRADITIONAL) ATTN: CHRISTOPHER P WHELAN PHONE NO : 508 588 4400 30 Doherty Avenue, P.O. Box 635 AvSE DECISION MADE: 22-OCT-13 Avon MA 02322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP VASCU-PICC WITH VALVE MEDCOMP (MEDICAL COMPONENTS) 510(k) NO: K130897(TRADITIONAL) ATTN: JESSICA LEO PHONE NO : 215 256 4201 1499 DELP DRIVE SE DECISION MADE: 22-OCT-13 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER MEDTRONIC INC. 510(k) NO: K132673(SPECIAL) ATTN: HEATHER MOROSE PHONE NO : 978 739 3187 37A CHERRY HILL DRIVE SE DECISION MADE: 22-OCT-13 DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133128(ABBREVIATED) ATTN: ASHA GARTLAND PHONE NO : 914 524 3257 511 BENEDICT AVE. SE DECISION MADE: 22-OCT-13 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAUTONA INJECTOR DEVICE TAUTONA GROUP, LLC 510(k) NO: K131963(TRADITIONAL) ATTN: JOE RIMSA PHONE NO : 650 331 2450 4040 CAMPBELL AVE, STE 110 SE DECISION MADE: 22-OCT-13 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K132990(SPECIAL) ATTN: DIANE NELSON PHONE NO : 763 255 0813 ONE SCIMED PLACE SE DECISION MADE: 22-OCT-13 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTICHEM S PLUS / S PLUS (ASSAYED) TECHNO-PATH MANUFACTURING LTD. 510(k) NO: K132751(ABBREVIATED) ATTN: STEPHANIE G GARTH PHONE NO : 469 230 0959 325 BIG ELM ST. SE DECISION MADE: 22-OCT-13 HIGHLAND VILLAGE TX 75077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM FLOW COUPLER DEVICE AND SYSTEM SYNOVIS LIFE TECHNOLOGIES, INC. 510(k) NO: K132727(SPECIAL) ATTN: TROY THOME PHONE NO : 651 796 7300 2575 UNIVERSITY AVE., STE.180 SE DECISION MADE: 22-OCT-13 ST. PAUL MN 55114 1024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS SMITH & NEPHEW, INC. 510(k) NO: K132435(TRADITIONAL) ATTN: MEGAN FESSENDEN PHONE NO : 901 399 1104 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 22-OCT-13 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISCOELASTIC INJECTOR SIGHT SCIENCES, INC. 510(k) NO: K132494(TRADITIONAL) ATTN: JUDY F GORDON D.V.M. PHONE NO : 949 715 0609 733 BOLSANA DRIVE SE DECISION MADE: 22-OCT-13 LAGUNA BEACH CA 92651 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIX LUMBAR SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC 510(k) NO: K131350(TRADITIONAL) ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8400 452 Alexandersville Rd SE DECISION MADE: 23-OCT-13 Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTUM TELEHEALTH APPLICATION OPTUMHEALTH CARE SOLUTIONS, INC. 510(k) NO: K130971(TRADITIONAL) ATTN: ROSHANA AHMED, MA, RAC PHONE NO : 905 690 5792 4 INNOVATION DR SE DECISION MADE: 23-OCT-13 DUNDAS, ON CA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE SMITH & NEPHEW, INC. 510(k) NO: K132446(SPECIAL) ATTN: LAURA REYNOLDS PHONE NO : 727 399 7702 970 LAKE CARILLON DR. SUITE 110 SE DECISION MADE: 23-OCT-13 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN WOUND DRESSING KERECIS LIMITED 510(k) NO: K132343(TRADITIONAL) ATTN: GUDMUNDUR F SIGURJONSSON PHONE NO : 354 562 2601 EYRARGATA 2 SE DECISION MADE: 23-OCT-13 ISAFIJORDUR IC 400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WMT IMPLANTABLE K-WIRE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K132895(TRADITIONAL) ATTN: LESLIE FITCH PHONE NO : 901 867 4409 5677 AIRLINE RD. SE DECISION MADE: 23-OCT-13 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HONSUN (NANTONG) CO., LTD. 510(k) NO: K132627(SPECIAL) ATTN: SELINA QIAN PHONE NO : 86 0513 80580116 NO.8, Tongxing Road, Nantong EconoSE DECISION MADE: 23-OCT-13 NANTONG, JIANGSU CH 226009 510(k) STATEMENT
DEVICE: EVOLUTION MP ADAPTIVE PS TIBIAL INSERT WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K131679(TRADITIONAL) ATTN: THERESA LEISTER PHONE NO : 901 290 5898 5677 AIRLINE RD. SE DECISION MADE: 23-OCT-13 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE PHILIPS MEDICAL SYSTEMS 510(k) NO: K131590(TRADITIONAL) ATTN: CHRISTINE TREFETHEN PHONE NO : 978 659 3890 3000 Minuteman Rd SE DECISION MADE: 23-OCT-13 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMESH -CICAT FEG TEXTILTECHNIK FORSCHUNGS-UND E510(k) NO: K131530(TRADITIONAL) ATTN: NEIL R ARMSTRONG PHONE NO : 011 44 1763222505 HERLINGTON HOUSE, ORTON MALBORNE SE DECISION MADE: 23-OCT-13 PETERBOROUGH, CAMBS. UK PE2 5XS510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX CSF CONTROLS LEVELS 2 AND 3 RANDOX LABORATORIES, LTD. 510(k) NO: K132156(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 028 944 22413 55 DIAMOND RD. SE DECISION MADE: 23-OCT-13 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX 2 SYSTEM STRYKER TRAUMA AG 510(k) NO: K132502(TRADITIONAL) ATTN: ELIJAH N WREH PHONE NO : 201 3 5691 325 CORPORATE DR SE DECISION MADE: 23-OCT-13 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN LLC 510(k) NO: K132493(SPECIAL) ATTN: KATHERINE KASSIM PHONE NO : 203 492 5299 60 MIDDLETOWN AVENUE SE DECISION MADE: 23-OCT-13 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOTUS SPINAL ELEMENTS, INC. 510(k) NO: K131427(TRADITIONAL) ATTN: BENJAMIN A KIMBALL PHONE NO : 760 607 1816 3115 MELROSE DRIVE STE 200 SE DECISION MADE: 24-OCT-13 CARLSBAD CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPRO – INFINITY PLATE ANCHOR SYSTEM BIOPRO, INC. 510(k) NO: K132510(TRADITIONAL) ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858 3150 E. 200TH ST SE DECISION MADE: 24-OCT-13 PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS CORE 3D PROTECH, S.L. 510(k) NO: K122295(ABBREVIATED) ATTN: ANNA CORTINA PHONE NO : 349 022828 48 POL. IND. SANTA ANNA APARTAT 20 SE DECISION MADE: 24-OCT-13 SANTPEDOR SP 08251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAK OSS FEMORAL KNEE COMPONENTS BIOMET ORTHOPEDICS CORP. 510(k) NO: K131393(TRADITIONAL) ATTN: GARY BAKER PHONE NO : 574 267 6639 56 EAST BELL DRIVE SE DECISION MADE: 24-OCT-13 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON S1000 / S2000 / S3000 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132804(TRADITIONAL) ATTN: CHRISTINE DUNN PHONE NO : 685 EAST MIDDLEFIELD ROAD SE DECISION MADE: 24-OCT-13 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: OMBRA TABLE TOP COMPRESSOR TRUDELL MEDICAL INTL. 510(k) NO: K131881(TRADITIONAL) ATTN: DARRYL FISCHER PHONE NO : 519 455 7060 725 THIRD ST. SE DECISION MADE: 24-OCT-13 LONDON CA N5V 5G4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACEM ULTRADENT PRODUCTS INC. / ORATECH 510(k) NO: K132255(TRADITIONAL) ATTN: DIANE E ROGER PHONE NO : 801 553 4491 10200 SOUTH 505 WEST SE DECISION MADE: 24-OCT-13 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DA01 BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION 510(k) NO: K132338(SPECIAL) ATTN: ERICA LI PHONE NO : 886 3359 6268 X8672 3F,6F, No.252, Shangying Road, GuiSE DECISION MADE: 24-OCT-13 Taoyuan County TW 33341 510(k) STATEMENT
DEVICE: SHEATHLESS EAUCATH CORONARY GUIDE CATHETER ASAHI INTECC CO., LTD. 510(k) NO: K132556(TRADITIONAL) ATTN: YOSHI TERAI PHONE NO : 949 756 8252 2500 RED HILL AVE, SUITE 210 SE DECISION MADE: 24-OCT-13 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGHTEST CONTROL SOLUTION BIONIME CORPORATION 510(k) NO: K133003(TRADITIONAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 24-OCT-13 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT CHURCH & DWIGHT CO., INC. 510(k) NO: K131887(TRADITIONAL) ATTN: EMILY PEREZ PHONE NO : 609 806 1430 500 CHARLES EWING BLVD SE DECISION MADE: 24-OCT-13 EWING NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: (QUANTA SYSTEM) SURGICAL LASER FIBERS QUANTA SYSTEM, S.P.A. 510(k) NO: K131473(TRADITIONAL) ATTN: MAURIZIO BIANCHI PHONE NO : 39 0331 376797 VIA IV NOVEMBRE,116 SE DECISION MADE: 24-OCT-13 SOLBIATE OLONA IT 21058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K131895(TRADITIONAL) ATTN: BRETT WHISTON PHONE NO : 64 9 5740100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 24-OCT-13 EAST TAMAKI NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIA FAN SYSTEM TRIA BEAUTY, INC. 510(k) NO: K130459(TRADITIONAL) ATTN: JONATHAN KAHAN PHONE NO : 202 638 5794 555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 25-OCT-13 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY BIO-RAD LABORATORIES 510(k) NO: K132227(TRADITIONAL) ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467 9500 JERONIMO RD. SE DECISION MADE: 25-OCT-13 IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRELLIS-8 PERIPHERAL INFUSION SYSTEM COVIDIEN 510(k) NO: K130904(TRADITIONAL) ATTN: JENNIFER SULLIVAN PHONE NO : 508 452 1659 15 HAMPSHIRE STREET SE DECISION MADE: 25-OCT-13 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLIGHT BIODYNAM BIOLIGHT AB 510(k) NO: K130866(SPECIAL) ATTN: PAR OLAUSSON LIDO PHONE NO : 46 0 86225270 WARFVINGES VAG 26 SE DECISION MADE: 25-OCT-13 STOCKHOLM SW SE 112 51 510(k) STATEMENT
DEVICE: COVAMESH BIOMUP S.A. 510(k) NO: K130428(TRADITIONAL) ATTN: VALERIE CENTIS PHONE NO : 33 04 86573610 8 ALLEE IRENE JOLIOT-CURIE SE DECISION MADE: 25-OCT-13 ST-PRIEST FR 69800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSEOSPEED PROFILE EV DENTSPLY IMPLANTS MANUFACTURING GM510(k) NO: K130999(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 12264 EL CAMINO REAL, SUITE 400 SE DECISION MADE: 25-OCT-13 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAUMEDIC-PTO-MONITORING-SYSTEM RAUMEDIC AG 510(k) NO: K130529(TRADITIONAL) ATTN: REINER THIEM PHONE NO : 004 992523 592782 HERRMANN-STAUDINGER-STR. 2 SE DECISION MADE: 25-OCT-13 HELMBRECHTS GM 95233 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: MIRADRY SYSTEM MIRAMAR LABS, INC. 510(k) NO: K131162(TRADITIONAL) ATTN: KATHY O’SHAUGHNESSY PHONE NO : 408 940 8700 445 INDIO WAY SE DECISION MADE: 25-OCT-13 SUNNYVALE CA 94085 4203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133124(ABBREVIATED) ATTN: GARO MIMARYAN PHONE NO : 914 524 3270 511 BENEDICT AVE. SE DECISION MADE: 25-OCT-13 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM INTELLIGENT IMPLANT SYSTEMS, LLC 510(k) NO: K132900(TRADITIONAL) ATTN: MICHAEL NUTT PHONE NO : 704 424 1009 3300 INTERNATIONAL AIRPORT DRIVE SSE DECISION MADE: 25-OCT-13 CHARLOTTE NC 28208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOGRAPHY VIEWER SMV658 FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K132188(TRADITIONAL) ATTN: JYH-SHYAN LIN PHONE NO : 301 251 1092 419 WEST AVE. SE DECISION MADE: 25-OCT-13 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDUSA VASCULAR PLUG ENDOSHAPE, INC. 510(k) NO: K123696(TRADITIONAL) ATTN: MICHAEL PARMENTER PHONE NO : 303 951 6898 2450 Central Ave Ste I SE DECISION MADE: 25-OCT-13 Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER COOK, INC. 510(k) NO: K132020(SPECIAL) ATTN: STEVEN LAWRIE PHONE NO : 812 335 3575 750 DANIELS WAY P.O. BOX 489 SE DECISION MADE: 25-OCT-13 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTINCT ENDOSCOPIC HEMOCLIP WILSON-COOK MEDICAL INC. 510(k) NO: K132809(SPECIAL) ATTN: SCOTTIE FARIOLE PHONE NO : 336 744 0157 4900 Bethania Station Rd SE DECISION MADE: 25-OCT-13 Winston Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNOSTIC ULTRASOUND SYSTEM ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K132059(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 WEST 20TH STREET SE DECISION MADE: 25-OCT-13 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TX WHEELCHAIR CHASSIS JCM SEATING SOLUTIONS LTD 510(k) NO: K131336(TRADITIONAL) ATTN: STUART R GOLDMAN PHONE NO : 512 327 9997 816 CONGRESS AVE. SUITE 1400 SE DECISION MADE: 28-OCT-13 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: JIAJIAN POINTOSELECT DIGITAL WUXI JIANJIAN MEDICAL INSTRUMENT C510(k) NO: K123958(TRADITIONAL) ATTN: DORIS DONG PHONE NO : 86 21 31261348 RM 1706, NO. 128 SONGLE RD. SONGJISE DECISION MADE: 28-OCT-13 SHANGHAI CH 201600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAUTILUS SPINAL SYSTEM LIFE SPINE, INC 510(k) NO: K132866(TRADITIONAL) ATTN: RANDY LEWIS PHONE NO : 847 884 6117 2401 W. HASSELL RD SUITE 1535 SE DECISION MADE: 28-OCT-13 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K131446(TRADITIONAL) ATTN: STEPHANIE N SHEESLEY PHONE NO : 717 840 3522 589 DAVIES DRIVE SE DECISION MADE: 28-OCT-13 YORK PA 17402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE MEDTRONIC, INC. 510(k) NO: K132972(SPECIAL) ATTN: JULIA A NELSON PHONE NO : 763 514 9844 7611 NORTHLAND DRIVE SE DECISION MADE: 28-OCT-13 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM SPECTRUM SPINE, LLC 510(k) NO: K132126(TRADITIONAL) ATTN: OTTIE PENDLETON PHONE NO : 404 372 0389 100 E. SOUTH MAIN ST. P.O. BOX 145SE DECISION MADE: 28-OCT-13 WAXHAW NC 28173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 MICRO VENTION, INC. 510(k) NO: K132083(TRADITIONAL) ATTN: LARAINE PANGELINA PHONE NO : 714 247 8000 1311 VALENCIA AVENUE SE DECISION MADE: 28-OCT-13 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITCLAMP 50 INNOVATIVE TRAUMA CARE INC 510(k) NO: K132651(TRADITIONAL) ATTN: RICHARD WAITE PHONE NO : 210 582 5850 3463 MAGIC DR. SUITE 120 SE DECISION MADE: 28-OCT-13 SAN ANTONIO TX 78229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYPATCH DMS-SERVICE LLC 510(k) NO: K131190(TRADITIONAL) ATTN: LYNDA S COLE PHONE NO : 775 315 0660 2800 NEILSON WAY, STE. 1 SE DECISION MADE: 29-OCT-13 SANTA MONICA CA 90405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPIRATION VENTILATOR SYSTEM 5I/7I EVENT MEDICAL LTD 510(k) NO: K130178(TRADITIONAL) ATTN: RICK WATERS PHONE NO : 949 492 8312 971CALLE AMANECER SUITE 101 SE DECISION MADE: 29-OCT-13 SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOUNDWASH SALINE SPRAY NEILMED PHARMACEUTICALS, INC. 510(k) NO: K123910(TRADITIONAL) ATTN: KETAN MEHTA PHONE NO : 707 525 3784 601 AVIATION BLVD. SE DECISION MADE: 29-OCT-13 SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.5MM INLINE FUSION PLATE BIOMET, INC. 510(k) NO: K131867(TRADITIONAL) ATTN: SUZANA OTANO PHONE NO : 305 269 6386 56 EAST BELL DR. BOX 587 SE DECISION MADE: 29-OCT-13 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS NETWORK MEDICAL PRODUCTS, LTD. 510(k) NO: K130117(TRADITIONAL) ATTN: ALISON MARCH PHONE NO : 440 176560 955 Coronet House, Kearsley Road SE DECISION MADE: 29-OCT-13 Ripon UK HG4 2SG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM ELITE SURGICAL SUPPLIES (PTY) LTD.510(k) NO: K130274(TRADITIONAL) ATTN: JOHN O’TOOLE PHONE NO : 27 12 3860012 184 BESSEMER ROAD SE DECISION MADE: 29-OCT-13 PRETORIA WEST INDU., GAUTENG SF510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVERSE SHOULDER PROSTHESIS MONOBLOCK ENCORE MEDICAL, L.P. 510(k) NO: K130048(TRADITIONAL) ATTN: TEFFANY HUTTO PHONE NO : 512 834 6255 9800 METRIC BLVD. SE DECISION MADE: 29-OCT-13 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDOR BIORESORBABLE MATRIX BARRIER SUNSTAR AMERICAS, INC. 510(k) NO: K132325(ABBREVIATED) ATTN: DEBORAH L GRAYESKI PHONE NO : 202 550 7395 575 8TH AVE, STE 1212 SE DECISION MADE: 29-OCT-13 NEW YORK NY 10018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIPLOMAT DIPLOMAT DENTAL S.R.O. 510(k) NO: K130534(TRADITIONAL) ATTN: STUART R GOLDMAN PHONE NO : 512 327 9997 816 CONGRESS AVENUE, SUITE 1400 SE DECISION MADE: 30-OCT-13 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIROTEL MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K130784(SPECIAL) ATTN: GERDA VAN HOUTS PHONE NO : 39 06 22754777 VIA DEL MAGGIOLINO 125 SE DECISION MADE: 30-OCT-13 ROMA IT 00155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNTOUCH EYE SPEAR HUIZHOU FORYOU MEDICAL DEVICES CO,510(k) NO: K132796(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 30-OCT-13 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW ULTRATAPE SMITH & NEPHEW, INC. 510(k) NO: K132357(SPECIAL) ATTN: MELODY BI PHONE NO : 508 337 4035 150 MINUTEMAN RD. SE DECISION MADE: 30-OCT-13 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS AJW TECHNOLOGY CONSULTANTS, INC. 510(k) NO: K131893(TRADITIONAL) ATTN: JANET DOUGLAS PHONE NO : 813 645 2855 445 APOLLO BEACH BLVD SE DECISION MADE: 30-OCT-13 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWER BONE SCREW SET FLOWER ORTHOPEDICS CORPORATION 510(k) NO: K132248(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST, 29TH FLOOR SE DECISION MADE: 30-OCT-13 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS MEDICAL DEVICES (PVT) LTD. 510(k) NO: K131719(TRADITIONAL) ATTN: TAUSEEF AJMAL PHONE NO : 009 252357 1214 WAZIRABAD RD. SE DECISION MADE: 30-OCT-13 UGOKI-SIALKOT PK PK 510(k) STATEMENT
DEVICE: MULTIVIEW HOLOGIC, INC. 510(k) NO: K132316(TRADITIONAL) ATTN: EILEEN M BOYLE PHONE NO : 781 999 7781 35 CROSBY DR. SE DECISION MADE: 30-OCT-13 BEDFORD MA 01730 510(k) STATEMENT
DEVICE: MESO BILAYER SURGICAL MESH KENSEY NASH CORPORATION DBA DSM BI510(k) NO: K132025(TRADITIONAL) ATTN: SUSAN PILEGGI PHONE NO : 484 713 2173 735 PENNSYLVANIA DRIVE SE DECISION MADE: 30-OCT-13 EXTON PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
适应症
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