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
