510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2013
TOTAL 510(k)s THIS PERIOD
TOTAL WITH SUMMARIES 225
TOTAL WITH STATEMENTS 17
DEVICE: FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
QUALIGEN, INC. 510(k) NO: K123983(TRADITIONAL)
ATTN: MICHAEL S POIRIER PHONE NO : 760 918 9165
2042 CORTE DEL NOGAL SUITE B SE DECISION MADE: 03-JUL-13
CARLSBAD CA 92011 1438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
THE BINDING SITE GROUP, LTD. 510(k) NO: K123256(TRADITIONAL)
ATTN: JILL CONSTANTINE PHONE NO : 440 121456 9500
8 CALTHORPE ROAD EDGBASTON SE DECISION MADE: 03-JUL-13
BIRMINGHAM, WEST MIDLANDS UK B1510(k) STATEMENT
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM – VANCOMYCIN (0.5-32 UG/ML)
BECTON, DICKINSON & CO. 510(k) NO: K131331(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410 316 4287
7 LOVETON CIR. SE DECISION MADE: 10-JUL-13
SPARKS MD 21152 0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
MICROGENICS CORP. 510(k) NO: K123343(TRADITIONAL)
ATTN: KAREN LEE PHONE NO : 510 979 5000
46360 FREMONT BLVD SE DECISION MADE: 11-JUL-13
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANA SCREEN ELISA (IGG)
EUROIMMUN US 510(k) NO: K131185(TRADITIONAL)
ATTN: MICHAEL LOCKE PHONE NO : 973 656 1000
1100 THE AMERICAN ROAD SE DECISION MADE: 15-JUL-13
MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 25OH VITAMIN D TOTAL ELISA TEST
DIASOURCE IMMUNOASSAYS, S.A. 510(k) NO: K123364(TRADITIONAL)
ATTN: NAPOLEON MONCE PHONE NO : 530 759 8000
2851 SPAFFORD ST SE DECISION MADE: 15-JUL-13
DAVIS CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN 25-OH VITAMIN D ELISA
EUROIMMUN US 510(k) NO: K123660(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973 656 1000
1100 THE AMERICAN ROAD SE DECISION MADE: 17-JUL-13
MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMDX VANR FOR ABBOTT M2000
INTELLIGENT MEDICAL DEVICES, IN510(k) NO: K123753(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978 927 3808
180 CABOT ST. SE DECISION MADE: 17-JUL-13
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
UCP BIOSCIENCES, INC. 510(k) NO: K131811(SPECIAL)
ATTN: NANCY CHEN PHONE NO : 408 392 0064
1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 19-JUL-13
SAN JOSE CA 95112 510(k) STATEMENT
DEVICE: GRAM-NEGATIVE QUICKFISH BC
ADVANDX, INC. 510(k) NO: K123418(TRADITIONAL)
ATTN: BENJAMIN S CRYSTAL PHONE NO : 781 376 0009
400 TradeCenter Suite 6990 SE DECISION MADE: 21-JUL-13
WOBURN MA 01801 510(k) STATEMENT
DEVICE: CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
CHEMTRON BIOTECH, INC. 510(k) NO: K131931(TRADITIONAL)
ATTN: JANE ZHANG PHONE NO : 858 530 2868
8370 JUNIPER CREEK LANE SUITE 1-2 SE DECISION MADE: 26-JUL-13
SAN DIEGO CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
SEBIA 510(k) NO: K130500(TRADITIONAL)
ATTN: KAREN ANDERSON PHONE NO : 800 835 6497
1705 CORPORATE DRIVE SUITE 400 SE DECISION MADE: 26-JUL-13
DULUTH GA 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K131754(TRADITIONAL)
ATTN: JOE SHIA PHONE NO : 240 505 7880
504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 31-JUL-13
GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
INFOPIA CO., LTD 510(k) NO: K130181(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 844 2612
1515 E KATELLA AVE UNIT 2115 SE DECISION MADE: 31-JUL-13
ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JBAIDS PLAGUE DETECTION KIT
BIOFIRE DIAGNOSTICS, INC. 510(k) NO: K131729(TRADITIONAL)
ATTN: CYNTHIA PHILLIPS PHONE NO : 801 736 6354
390 WAKARA WAY SE DECISION MADE: 31-JUL-13
Emigration Canyon UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JBAIDS TULAREMIA DETECTION KIT
BIOFIRE DIAGNOSTICS, INC. 510(k) NO: K131936(TRADITIONAL)
ATTN: CYNTHIA PHILIPS PHONE NO : 801 736 6354
390 WAKARA WAY SE DECISION MADE: 31-JUL-13
SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEATER-COOLER UNIT HCU 40
MAQUET CARDIOPULMONARY AG 510(k) NO: K130300(TRADITIONAL)
ATTN: HELDER A SOUSA PHONE NO : 973 709 7465
45 BARBOUR POND DRIVE SE DECISION MADE: 01-JUL-13
WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
STERNGOLD DENTAL LLC 510(k) NO: K130408(ABBREVIATED)
ATTN: MARIA RAO PHONE NO : 508 226 5660
23 Frank Mossberg Drive SE DECISION MADE: 01-JUL-13
Attleboro MA 02703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELLEX 2RT
ELLEX MEDICAL PTY. LTD. 510(k) NO: K122202(TRADITIONAL)
ATTN: KEVIN HOWARD PHONE NO : 618 810 45200
82 GILBERT ST. SE DECISION MADE: 01-JUL-13
ADELAIDE, SOUTH AUSTRALIA AS 50510(k) STATEMENT
DEVICE: COOK HOLMIUM LASER FIBER
COOK INCORPORATED 510(k) NO: K124030(SPECIAL)
ATTN: CONNIE RICE PHONE NO : 812 339 2235
750 DANIELS WAY SE DECISION MADE: 01-JUL-13
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
PIPELINE ORTHOPEDICS 510(k) NO: K130353(TRADITIONAL)
ATTN: TERRY POWELL PHONE NO : 703 562 9800
901 KING STREET, SUITE 200 SE DECISION MADE: 01-JUL-13
ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRONA DVT FOOT GARMENT
DEVON MEDICAL INC. 510(k) NO: K131743(TRADITIONAL)
ATTN: RUTH WU PHONE NO : 610 757 4103
1100 1ST AVENUE SUITE 100 SE DECISION MADE: 01-JUL-13
KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K131705(SPECIAL)
ATTN: KATHERINE ROBERTSON PHONE NO : 203 492 5299
60 Middletown Ave SE DECISION MADE: 01-JUL-13
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCELLERA
VOMARIS INNOVATIONS INC. 510(k) NO: K130350(TRADITIONAL)
ATTN: JEFFRY SKIBA PHONE NO : 480 921 4948
3100 W. Ray Rd, Ste 148 SE DECISION MADE: 02-JUL-13
Chandler AZ 85226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDK MULTI-APPLICATIONS PLATFORM
QUANTA SYSTEM SPA 510(k) NO: K130256(TRADITIONAL)
ATTN: MAURIZIO BIANCHI PHONE NO : 390 331376 797
VIA IV NOVEMBRE 116 SE DECISION MADE: 02-JUL-13
SOLBIATE OLONA (VA) IT 21058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
MERCATOR MEDSYSTEMS, INC. 510(k) NO: K131401(TRADITIONAL)
ATTN: PLAMENA ENTCHEVA-DIMITROV, PHONE NO : 510 614 4550
1670 ALVARADO SUITE #4 SE DECISION MADE: 02-JUL-13
SAN LEANDRO CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VIDA PTV DILATATON CATHETER
C.R. BARD, INC. 510(k) NO: K131002(TRADITIONAL)
ATTN: AARON CONOVALOFF PHONE NO : 480 350 6012
1625 WEST 3RD ST. SE DECISION MADE: 02-JUL-13
TEMPE AZ 85281 1740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFIX SPINOUS PROCESS PLATE SYSTEM
NUVASIVE, INC. 510(k) NO: K131238(TRADITIONAL)
ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515
7475 LUSK BLVD SE DECISION MADE: 02-JUL-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSUS
NEUROMETRIX, INC. 510(k) NO: K130919(TRADITIONAL)
ATTN: RAINER MAAS PHONE NO : 781 314 2781
62 FOURTH AVE. SE DECISION MADE: 02-JUL-13
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORRECT PLUS 1
PENTRON CLINICAL 510(k) NO: K130920(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602
1717 WEST COLLINS AVENUE SE DECISION MADE: 02-JUL-13
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE TURBINATOR WAND
ARTHROCARE CORPORATION 510(k) NO: K122652(TRADITIONAL)
ATTN: CHERYL FREDERICK PHONE NO : 512 358 5751
7000 W William Cannon Dr SE DECISION MADE: 02-JUL-13
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
REVERSE MEDICAL CORPORATION 510(k) NO: K123803(TRADITIONAL)
ATTN: JEFFREY VALKO PHONE NO : 949 215 0660
13700 ALTON PARKWAY SUITE 167 SE DECISION MADE: 02-JUL-13
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
RAYENCE CO., LTD 510(k) NO: K130935(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607
12946 KIMBERLEY LN SE DECISION MADE: 02-JUL-13
HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBIS II
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K131372(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457
PO BOX 566 SE DECISION MADE: 02-JUL-13
CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
LINVATEC CORPORATION D/B/A CONMED 510(k) NO: K131035(SPECIAL)
ATTN: JOY LOVETT PHONE NO : 727 399 5137
11311 Concept Boulevard SE DECISION MADE: 02-JUL-13
LARGO FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWTOM VGI AND NEWTOM 5G
QR S.R.L. 510(k) NO: K130442(TRADITIONAL)
ATTN: BERTHOIN CLAUDE PHONE NO : 386 672 2630
110 E. GRANADA BLVD. SUITE 207 SE DECISION MADE: 03-JUL-13
ORMOND BEACH FL 32176 510(k) STATEMENT
DEVICE: DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K120977(TRADITIONAL)
ATTN: LAWRENCE PICCIANO PHONE NO : 732 548 5700
23 NEVSKY ST. SE DECISION MADE: 03-JUL-13
EDISON NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2008K@HOME HEMODIALYSIS MACHINE
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K124035(TRADITIONAL)
ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479
920 WINTER STREET SE DECISION MADE: 03-JUL-13
WALTHAM MA 02451 1457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
CANON INC. 510(k) NO: K131106(TRADITIONAL)
ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554
1201 RICHARDSON DRIVE, SUITE 280 SE DECISION MADE: 03-JUL-13
RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABSOCLEAR
PHARMAPLAST S.A.E. 510(k) NO: K130553(TRADITIONAL)
ATTN: CYNTHIA PRITCHARD PHONE NO : 919 676 6185
1016 TOBIANO LANE SE DECISION MADE: 03-JUL-13
RALEIGH NC 27614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
HERTART 510(k) NO: K123641(TRADITIONAL)
ATTN: HENRIK DORGE PHONE NO : 453 691 5170
KORSKILDELUND 6 SE DECISION MADE: 03-JUL-13
GREVE DA 2670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K123074(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 03-JUL-13
GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
LASERSTIM, INC. 510(k) NO: K123177(TRADITIONAL)
ATTN: DAVID C FURR PHONE NO : 512 906 9654
8708 CAPEHART COVE SE DECISION MADE: 03-JUL-13
AUSTIN TX 78733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
HORIBA ABX S.A.S. 510(k) NO: K123171(ABBREVIATED)
ATTN: CAROLINE FERRER PHONE NO : 330 4 67141843
PARC EUROMEDECINE RUE DU CADUCEE-BSE DECISION MADE: 03-JUL-13
MONTPELLIER CEDEX 4, HERAULT FR510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
MENICON CO. LTD. 510(k) NO: K130805(TRADITIONAL)
ATTN: ELLEN M BEUCLER PHONE NO : 978 658 6888
187 BALLARDVALE STREET SUITE 180 SE DECISION MADE: 03-JUL-13
WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFUSION
OPTOVUE, INC. 510(k) NO: K130656(SPECIAL)
ATTN: WILLIAM "BILL" JACKSON PHONE NO : 510 623 8868
2800 Bayview Dr SE DECISION MADE: 03-JUL-13
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBER TM FAMILY
QUANTA SYSTEM SPA 510(k) NO: K131081(TRADITIONAL)
ATTN: MAURIZIO BIANCHI PHONE NO : 39 0331 376797
VIA IV NOVEMBRE, 116 SE DECISION MADE: 03-JUL-13
SOLBIATE OLONA (VA) IT 21058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2MP COLOR LCD MONITOR, RADIFORCE MX215
EIZO CORPORATION 510(k) NO: K131090(TRADITIONAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO SE DECISION MADE: 03-JUL-13
HAKUSAN, ISHIKAWA JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNASTY ACETABULAR SYSTEM WITH CERAMIC
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K130376(TRADITIONAL)
ATTN: DEAN NACHTRAB PHONE NO : 901 290 5812
5677 AIRLINE RD. SE DECISION MADE: 03-JUL-13
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE – LEFT & RIGHT
EXACTECH, INC. 510(k) NO: K131575(SPECIAL)
ATTN: PATRICK HUGHES PHONE NO : 352 327 4762
2320 N.W. 66TH CT. SE DECISION MADE: 03-JUL-13
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
EMERGE MEDICAL 510(k) NO: K131480(TRADITIONAL)
ATTN: VICTORIA TRAFKA PHONE NO : 303 225 7909
790 S. COLORADO BLVD SUITE 550-S SE DECISION MADE: 03-JUL-13
DENVER CO 80246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CP150 ELECTROCARDIOGRAPH
WELCH ALLYN, INC. 510(k) NO: K131573(SPECIAL)
ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609
4341 STATE ST. RD. P.O. BOX 220 SE DECISION MADE: 03-JUL-13
SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
BIOMET, INC. 510(k) NO: K131670(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305 269 6386
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 03-JUL-13
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX DISTAL RADIUS PLATE SYSTEM
ARTHREX, INC. 510(k) NO: K131474(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 03-JUL-13
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K131786(TRADITIONAL)
ATTN: ROBERT ANDREW MILLER PHONE NO : 210 363 8753
335 E. SONTERRA BLVD. SUITE 200 SE DECISION MADE: 03-JUL-13
SAN ANTONIO TX 78258 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: ETII SA FIXTURE SYSTEM
HIOSSEN INC. 510(k) NO: K123471(TRADITIONAL)
ATTN: PATRICK LIM PHONE NO : 888 679 0001
85 BEN FAIRLESS DRIVE SE DECISION MADE: 05-JUL-13
FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS
SPS MEDICAL SUPPLY CORP. 510(k) NO: K130211(SPECIAL)
ATTN: MICHAEL G NOLAN PHONE NO : 585 359 0130
6789 WEST HENRIETTA RD. SE DECISION MADE: 05-JUL-13
RUSH NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSCORP ACIF SYSTEM
TRANSCORP, INC. 510(k) NO: K121178(SPECIAL)
ATTN: ANDREW RODENHOUSE PHONE NO : 616 855 5375
1000 100TH ST. SW, SUITE F SE DECISION MADE: 05-JUL-13
BYRON CENTER MI 49315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISUS IMPLANT SUPRASTRUCTURES
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K122424(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717 845 4229
SUSQUEHANNA COMMERCE CTR., 221 W. SE DECISION MADE: 05-JUL-13
YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K131283(TRADITIONAL)
ATTN: DANIELLE MUELLER PHONE NO : 901 290 5904
5677 AIRLINE RD. SE DECISION MADE: 05-JUL-13
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERMIS STERILIZATION CONTAINER SYSTEM
ERMIS MEDIZINTECHNIK 510(k) NO: K123234(TRADITIONAL)
ATTN: ANDRE WEINGERL PHONE NO : 497 463995 40
GRIESWEG 47 SE DECISION MADE: 05-JUL-13
MUEHLHEIM, BADEN-WUERTTEMBERG G510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
HARTALEGA SDN BHD 510(k) NO: K130473(TRADITIONAL)
ATTN: NURUL AISYAH KONG BT ABDULLPHONE NO : 603 327102 77
NO. 7, KAWASAN PERUSAHAAN SURIA SE DECISION MADE: 05-JUL-13
BESTARI JAYA MY 45600 510(k) STATEMENT
DEVICE: TIBURON SURGICAL DRAPE
CARDINAL HEALTH 200, LLC 510(k) NO: K130404(TRADITIONAL)
ATTN: LAVENIA FORD PHONE NO : 847 887 3323
1430 WAUKEGAN ROAD SE DECISION MADE: 05-JUL-13
WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
STERIS CORPORATION 510(k) NO: K131078(SPECIAL)
ATTN: MARCIA L BENEDICT PHONE NO : 440 392 7063
5960 HEISLEY SE DECISION MADE: 05-JUL-13
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLICKFINE AUTOPROTECT PEN NEEDLE
YPSOMED AG 510(k) NO: K131123(TRADITIONAL)
ATTN: BENJAMIN REINMANN PHONE NO : 004 1344 244117
BRUNNMATTSTRASSE 6 SE DECISION MADE: 05-JUL-13
BURGDORF SZ CH-3401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLICKFINE PEN NEEDLE
YPSOMED AG 510(k) NO: K131125(TRADITIONAL)
ATTN: BENJAMIN REINMANN PHONE NO : 004 1344 243117
BRUNNMATTSTRASSE 6 SE DECISION MADE: 05-JUL-13
BURGDORF SZ CH-3401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
CHANGZHOU SINOLINKS MEDICAL INNOVA510(k) NO: K131511(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 212281 5850
P.O. BOX 120-119 SE DECISION MADE: 05-JUL-13
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICK VUE INFLUENZA
QUIDEL CORPORATION 510(k) NO: K131599(SPECIAL)
ATTN: JOHN D TAMERIUS, PH.D. PHONE NO : 858 552 7908
10165 MCKELLAR COURT SE DECISION MADE: 05-JUL-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECTALIF
MEDACTA INTERNATIONAL 510(k) NO: K131671(SPECIAL)
ATTN: ADAM GROSS PHONE NO : 805 322 3289
4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 05-JUL-13
CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
MAQUET CARDIOPULMONARY AG 510(k) NO: K131666(SPECIAL)
ATTN: SARAH BETZ PHONE NO : 011 497478 9210
NEUE ROTTENBURGER STR. 37 SE DECISION MADE: 05-JUL-13
HECHINGEN GM 72379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFIA INFLUENZA A+B FIA
QUIDEL CORP. 510(k) NO: K131606(SPECIAL)
ATTN: JOHN D TAMERIUS, PH.D. PHONE NO : 858 552 7908
10165 MCKELLAR CT. SE DECISION MADE: 05-JUL-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SFI BAR ABUTMENTS
STERNGOLD DENTAL LLC 510(k) NO: K130183(ABBREVIATED)
ATTN: MARIA RAO PHONE NO : 508 226 5660
23 Frank Mossberg Drive SE DECISION MADE: 07-JUL-13
Attleboro MA 02703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBIO REMOTE HEALTH MONITORING SYSTEM
ARRAYENT HEALTH LLC D/B/A AMBIO HE510(k) NO: K130676(TRADITIONAL)
ATTN: KEVIN JONES PHONE NO : 973 568 0323
1266 EAST MAIN STREET SUITE 700R SE DECISION MADE: 08-JUL-13
STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIST AUTOMATIC BLOOD PRESSURE MONITOR
HONSUN (NANTONG) CO., LTD 510(k) NO: K131463(TRADITIONAL)
ATTN: SELINA QIAN PHONE NO : 86 0513 80580022
ADD: NO8 TONGXING ROAD SE DECISION MADE: 08-JUL-13
JIANGSU CH 226009 510(k) STATEMENT
DEVICE: NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE – IV PLUS
NEXUS MEDICAL, LLC 510(k) NO: K130879(TRADITIONAL)
ATTN: HEATHER TURNER PHONE NO : 913 451 2234
11315 STRANG LINE ROAD SE DECISION MADE: 09-JUL-13
LENEXA KS 66215 510(k) STATEMENT
DEVICE: STATSEAL DISC
BIOLIFE, LLC 510(k) NO: K130324(TRADITIONAL)
ATTN: CLAUDIA MASSELINK PHONE NO : 941 360 1300
9163 25TH COURT EAST SE DECISION MADE: 09-JUL-13
SARASOTA FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
COLOPLAST A/S 510(k) NO: K131072(TRADITIONAL)
ATTN: BRIAN SCHMIDT PHONE NO : 612 302 4987
1601 WEST RIVER ROAD N SE DECISION MADE: 09-JUL-13
MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DLP CORONARY OSTIAL PERFUSION CANNULAE
MEDTRONIC, INC. 510(k) NO: K131269(SPECIAL)
ATTN: KEVIN T LAM PHONE NO : 763 526 2360
7611 NORTHLAND DRIVE SE DECISION MADE: 10-JUL-13
MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSEFORCE IMPLANT SYSTEM
SOLANA SURGICAL, LLC 510(k) NO: K124045(TRADITIONAL)
ATTN: JOE CLIFT PHONE NO : 901 818 1860
6363 POPLAR AVENUE SUITE 312 SE DECISION MADE: 10-JUL-13
MEMPHIS TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMA HOOD
GLOBALMEDIA GROUP, LLC 510(k) NO: K131338(TRADITIONAL)
ATTN: NICHOLAS CAMPBELL PHONE NO : 480 922 0044
15020 N. 74TH ST. SE DECISION MADE: 10-JUL-13
SCOTTSDALE AZ 85260 510(k) STATEMENT
DEVICE: EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
BOSTON SCIENTIFIC CORP. 510(k) NO: K130391(TRADITIONAL)
ATTN: VICKY L HAGENS PHONE NO : 763 255 0303
TWO SCIMED PLACE SE DECISION MADE: 10-JUL-13
MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QDC-PRO, AND NOX-RIP
NOX MEDICAL 510(k) NO: K124062(TRADITIONAL)
ATTN: KOLBRUN E OTTOSDOTTIR PHONE NO : 354 570717 0
VATNAGORDUM 18 SE DECISION MADE: 10-JUL-13
REYKJAVIK IC 104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS RX N MEDIUM; AIGIS RX N LARGE
TYRX ,INC 510(k) NO: K131007(TRADITIONAL)
ATTN: SUSAN OLINGER PHONE NO : 732 964 1110
1 DEER PARK DRIVE SUITE G SE DECISION MADE: 10-JUL-13
MONMOUTH JUNCTION NJ 08852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H
PHADIA AB 510(k) NO: K131738(SPECIAL)
ATTN: CARINA MAGNUSSON PHONE NO : 46 18 165000
RAPSGATAN 7 P.O. BOX 6460 SE DECISION MADE: 10-JUL-13
UPPSALA SW SE – 75137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
BSN MEDICAL, INC. 510(k) NO: K131496(SPECIAL)
ATTN: CARROLL D HOYLE PHONE NO : 828 879 5100
100 BEIERSDORF DRIVE SE DECISION MADE: 10-JUL-13
RUTHERFORD COLLEGE NC 28671 510(k) STATEMENT
DEVICE: STIMEL-03
STIMEL LTD 510(k) NO: K130424(TRADITIONAL)
ATTN: RAYMOND J KELLY IV PHONE NO : 203 880 4091
57 LAZY BROOK ROAD SE DECISION MADE: 11-JUL-13
MONROE CT 06468 510(k) STATEMENT
DEVICE: NXSTAGE DOSING CALCULATOR
NXSTAGE MEDICAL, INC. 510(k) NO: K130460(TRADITIONAL)
ATTN: NNAMDI NWACHUKWU PHONE NO : 978 332 8477
350 Merrimack St SE DECISION MADE: 11-JUL-13
LAWRENCE MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONTERIS MEDICAL NEUROBLATE SYSTEM
MONTERIS MEDICAL, INC. 510(k) NO: K131278(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 510 337 0140
1193 SHERMAN ST SE DECISION MADE: 11-JUL-13
ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXUS HEMORRHOID LIGATOR
INX MEDICAL 510(k) NO: K131282(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
1819 CLARKSON ROAD SUITE 206 SE DECISION MADE: 11-JUL-13
CHESTERFIELD MO 63017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSINE SAMARITAN PAD 350P
HEARTSINE TECHNOLOGIES, INC. 510(k) NO: K123881(TRADITIONAL)
ATTN: JAMES MCGUINNESS PHONE NO : 442 890939 419
203 AIRPORT ROAD WEST BELFAST SE DECISION MADE: 11-JUL-13
NORTHERN EI BT3 9ED 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETCH GEL
DMG AMERICA, LLC 510(k) NO: K131248(TRADITIONAL)
ATTN: PAMELA PAPINEUA, RAC PHONE NO : 978 772 3552
5 WHITCOMB AVENUE SE DECISION MADE: 11-JUL-13
AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE
SILVERBAY LLC, D/B/A QUASAR BIO-TE510(k) NO: K130225(TRADITIONAL)
ATTN: ROBERT WAGNER PHONE NO : 865 982 5552
2424DEMPSTER DRIVE SE DECISION MADE: 11-JUL-13
CORALVILLE IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MESOTHELIUM DENTAL MEMBRANE
KENSEY NASH CORPORATION 510(k) NO: K121310(TRADITIONAL)
ATTN: LORI BURNS, MS, RAC PHONE NO : 484 713 2100
735 PENNSYLVANIA DRIVE SE DECISION MADE: 11-JUL-13
EXTON PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINICAL ALERT NOTIFICATION
EXTENSION , INC 510(k) NO: K130339(TRADITIONAL)
ATTN: TIM GEE PHONE NO : 503 481 2370
7250 SW 154TH TERRACE SE DECISION MADE: 11-JUL-13
BEAVERTON OR 97007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K123075(ABBREVIATED)
ATTN: CHIN-CHIH HSIEH PHONE NO : 886 2 29282112
1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 11-JUL-13
YUNGHE CITY, TAIPEI COUNTY TW C510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXUS ANTERIOR CERVICAL PLATE SYSTEM
CORE-NEXUS 510(k) NO: K131520(SPECIAL)
ATTN: LISA PETERSON PHONE NO : 512 507 0746
14001 HUNTERS PASS SE DECISION MADE: 11-JUL-13
AUSTIN TX 78734 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGITRON 4.0 DUAL RF S5-IEC
ELLMAN INTERNATIONAL, INC. 510(k) NO: K123366(TRADITIONAL)
ATTN: ALISON SATHE PHONE NO : 513 658 8960
3333 ROYAL AVENUE SE DECISION MADE: 12-JUL-13
OCEANSIDE NY 11572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FACET FIXX
NEXXT SPINE LLC 510(k) NO: K131417(TRADITIONAL)
ATTN: KAREN E WARDEN PHD PHONE NO : 440 729 8457
8202 SHERMAN ROAD SE DECISION MADE: 12-JUL-13
CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YAMAHACHI DENTURE BASE RESINS
YAMAHACHI DENTAL MANUFACTURING CO.510(k) NO: K131036(TRADITIONAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 0450
110 EASTGRANADA BLVD. SUITE 209 SE DECISION MADE: 12-JUL-13
ORMOND BEACH FL 32176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLEA
CONVERGENT DENTAL, INC 510(k) NO: K130420(TRADITIONAL)
ATTN: CARRIE HETRICK PHONE NO : 512 327 9997
611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 12-JUL-13
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPULSE HAIR REMOVAL SYSTEM
CYDEN LIMITED 510(k) NO: K130315(TRADITIONAL)
ATTN: DAVID BRODERICK PHONE NO : 44 1792 485755
TECHNIUM 2, KINGS ROAD SE DECISION MADE: 12-JUL-13
SWANSEA, WEST GLAMORGAN UK SA1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIPLATFORM MEDICAL IMAGING SUITE
HINACOM SOFTWARE AND TECHNOLOGY, L510(k) NO: K131424(TRADITIONAL)
ATTN: YI ISABELLE SUN PHONE NO : 86 10 62701653
SUITE B301, R&D PLAZA, TSINGHUA SCSE DECISION MADE: 12-JUL-13
BEIJING CH 100084 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PADSCAN HD SERIES BLADDER SCANNER
CARENOSO TECHNOLOGY CO., LTD. 510(k) NO: K131227(TRADITIONAL)
ATTN: ZHANG WENSHENG PHONE NO : 86 415 6123779
4TH FL, NO. 11 BLDG INITIATING ZONSE DECISION MADE: 12-JUL-13
DANDONG, LIAONING CH 118009 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INGENUITY DIGITAL PET/CT
PHILIPS HEALTHCARE (CLEVELAND) 510(k) NO: K123599(TRADITIONAL)
ATTN: MICHAEL S PRETO PHONE NO : 440 483 2295
595 MINER RD. SE DECISION MADE: 12-JUL-13
CLEVELAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K130806(SPECIAL)
ATTN: CHRISTINE VERGELY PHONE NO : 805 866 6999
2225 SPERRY AVE, SUITE 1000 SE DECISION MADE: 12-JUL-13
VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPSTANK REUSABLE SHARPS CONTAINER
REHRIG PACIFIC COMPANY 510(k) NO: K131087(ABBREVIATED)
ATTN: DAVID OLMSTEAD PHONE NO : 615 210 4698
614 HUNTERS LANE SE DECISION MADE: 12-JUL-13
BRENTWOOD TN 37027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMEL XPECT FLU A&B
REMEL, INC. 510(k) NO: K131804(SPECIAL)
ATTN: CINDY KNAPP PHONE NO : 800 871 8909
12076 Santa Fe Dr SE DECISION MADE: 12-JUL-13
LENEXA KS 66215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
ROTATION MEDICAL, INC. 510(k) NO: K131637(TRADITIONAL)
ATTN: GAIL SCHROEDER PHONE NO : 763 746 7521
15350 25TH AVENUE N SUITE 100 SE DECISION MADE: 12-JUL-13
PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
GE VINGMED ULTRASOUND AS 510(k) NO: K131514(SPECIAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214
9900 W INNOVATION DR., RP-2138 SE DECISION MADE: 12-JUL-13
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANX FUSION SYSTEM
LANX, INC. 510(k) NO: K131547(SPECIAL)
ATTN: ALAN BURKHOLDER PHONE NO : 303 442 7500
310 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 12-JUL-13
BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 611 ANKLE FUSION NAIL
TORNIER SAS 510(k) NO: K130051(TRADITIONAL)
ATTN: DAMIEN GUILLAUD PHONE NO : 003 347 6613500
161 RUE LAVOISIER SE DECISION MADE: 15-JUL-13
MONTBONNOT CEDEX FR 38334 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTEK EASY BRUSH WITH FLUORIDE
DENTEK ORAL CARE, INC. 510(k) NO: K130186(TRADITIONAL)
ATTN: LINDA GILES PHONE NO : 865 983 1300
307 EXCELLENCE WAY SE DECISION MADE: 15-JUL-13
MARYVILLE TN 37801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOTIS; NEOTIS 50
SBM SCIENCES FOR BIO MATERIALS 510(k) NO: K130953(SPECIAL)
ATTN: DENIS CLEMENT PHONE NO : 33 562422 101
ZI DU MONGE SE DECISION MADE: 15-JUL-13
LOURDES FR 65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTAVIPRO STERICAN 30G
B. BRAUN MELSUNGEN AG 510(k) NO: K131040(TRADITIONAL)
ATTN: KARIN LUBBERS PHONE NO : 49 617276 464886
BAHNSTRASSE 42-46 SE DECISION MADE: 15-JUL-13
FRIEDRICHSDORF, HESSE GM 61381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
VATECH CO., LTD. 510(k) NO: K130585(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607
12946 KIMBERLEY LN SE DECISION MADE: 15-JUL-13
HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
BECKMAN COULTER, INC. 510(k) NO: K130253(TRADITIONAL)
ATTN: NANCY NADLER PHONE NO : 305 380 4191
11800 SW 147 AVE SE DECISION MADE: 15-JUL-13
MIAMI FL 33196 2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
ALL MEDICUS CO., LTD 510(k) NO: K130657(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
1515 E. KATELLA AVE. UNIT 2115 SE DECISION MADE: 15-JUL-13
ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
INVIVO CORPORATION 510(k) NO: K131382(SPECIAL)
ATTN: RUSTY KELLY PHONE NO : 407 455 6166
12151 RESEARCH PKWY SE DECISION MADE: 15-JUL-13
ORLANDO FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM – MULTI-USER VERSION
CONSTANT CARE, LLC 510(k) NO: K130360(TRADITIONAL)
ATTN: SETH A MAILHOT PHONE NO : 202 469 4980
1300 I ST, NW, 11TH FLOOR EAST SE DECISION MADE: 15-JUL-13
WASHINGTON DC 20005 3314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUSCOPE SERIES PATIENT MONITOR
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K131763(SPECIAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 15-JUL-13
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADVISION
ACOUSTIC MEDSYSTEMS, INC. 510(k) NO: K131428(TRADITIONAL)
ATTN: JENNIFER WILLIAMS PHONE NO : 217 239 0900
208 BURWASH AVE. SE DECISION MADE: 16-JUL-13
SAVOY IL 61874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPORT ADVANCE ASPIRATION CATHETER
MEDTRONIC INC. 510(k) NO: K130536(TRADITIONAL)
ATTN: COLLEEN MULLINS PHONE NO : 978 739 3267
37A CHERRY HILL DRIVE SE DECISION MADE: 16-JUL-13
DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LPP (LOW PROFILE PORT)
PFM MEDICAL, INC 510(k) NO: K122402(TRADITIONAL)
ATTN: SALVADORE PALOMARES, RAC PHONE NO : 760 758 8749
1815 ASTON AVE, SUITE 106 SE DECISION MADE: 16-JUL-13
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERMES MEDICAL IMAGING SUITE V5.3
HERMES MEDICAL SOLUTIONS, AB 510(k) NO: K131233(TRADITIONAL)
ATTN: JOAKIM ARWIDSON PHONE NO : 46 819032 5
SKEPPSBRON 44 SE DECISION MADE: 16-JUL-13
STOCKHOLM SW 111 30 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PEN NEEDLE
BECTON DICKINSON & CO. 510(k) NO: K131358(TRADITIONAL)
ATTN: PASQUALE AMATO PHONE NO : 201 847 4513
1 BECTON DRIVE MC 372 SE DECISION MADE: 16-JUL-13
FRANKLIN LAKES NJ 07417 1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
STERIS CORPORATION 510(k) NO: K131120(TRADITIONAL)
ATTN: BILL BRODBECK PHONE NO : 440 392 7690
5960 HEISLEY ROAD SE DECISION MADE: 16-JUL-13
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
VISIONSENSE, LTD. 510(k) NO: K131434(SPECIAL)
ATTN: GERARD J PRUD’HOMME PHONE NO : 202 637 5735
555 13TH STREET, NW SE DECISION MADE: 16-JUL-13
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL OPAQUE
SHOFU DENTAL CORPORATION 510(k) NO: K131504(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760 736 3277
1225 STONE DRIVE SE DECISION MADE: 16-JUL-13
SAN MARCOS CA 92078 510(k) STATEMENT
DEVICE: DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
DEMETECH CORP. 510(k) NO: K130083(TRADITIONAL)
ATTN: ANTHONY J DIMERCURIO PHONE NO : 305 824 1048
14175 NW 60th Ave SE DECISION MADE: 17-JUL-13
Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFE SPINE PLATEAU SPACER SYSTEM
LIFE SPINE 510(k) NO: K131077(TRADITIONAL)
ATTN: RANDY LEWIS PHONE NO : 847 884 6117
2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 17-JUL-13
HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOFLIP CATHETER
CROSPON, LTD. 510(k) NO: K130906(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 17-JUL-13
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
COOK, INC. 510(k) NO: K130766(SPECIAL)
ATTN: DAVID LEHR PHONE NO : 812 339 2235
750 DANIELS WAY SE DECISION MADE: 17-JUL-13
Blmgtn IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
MENTOR WORLDWIDE LLC 510(k) NO: K131853(SPECIAL)
ATTN: MANCHI CHEUNG PHONE NO : 805 879 6790
201 MENTOR DRIVE SE DECISION MADE: 17-JUL-13
SANTA BARBARA CA 93111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GREENCROSS SURGICAL MASK
JINGZHOU HAIXIN GREEN CROSS MEDICA510(k) NO: K123787(TRADITIONAL)
ATTN: XIANGYANG SONG PHONE NO : 312 479 0030
6 VANDERBLET ROAD SE DECISION MADE: 17-JUL-13
ACTON MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALUTRODE NEUROSTIMLATION ELECTRODES
AXELGAARD MFG. CO., LTD. 510(k) NO: K130987(TRADITIONAL)
ATTN: DAN P JEFFERY PHONE NO : 760 451 8000
520 INDUSTRIAL WAY SE DECISION MADE: 17-JUL-13
FALLBROOK CA 92028 2244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS C BILIRUBIN TOTAL GEN.3
ROCHE DIAGNOSTICS 510(k) NO: K131544(TRADITIONAL)
ATTN: LISA K KLINEDINST PHONE NO : 317 521 1942
9115 SOUTH HAGUE ROAD SE DECISION MADE: 17-JUL-13
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRYLIC HERBST APPLIANCE
GERGENS ORTHODONTIC LAB 510(k) NO: K113126(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD PHONE NO : 623 879 6066
11825 State Route 40 Ste 101 SE DECISION MADE: 17-JUL-13
Dunlap IL 61525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
THORATEC CORP 510(k) NO: K131179(SPECIAL)
ATTN: YVERRE BOBAY PHONE NO : 781 852 8276
23 4th Ave SE DECISION MADE: 18-JUL-13
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC. 510(k) NO: K131467(TRADITIONAL)
ATTN: AMITA SHAH PHONE NO : 781 345 9164
28 Crosby Dr SE DECISION MADE: 18-JUL-13
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICT
IMRIS, INC. 510(k) NO: K130224(TRADITIONAL)
ATTN: DANIEL BIANK PHONE NO : 952 358704 6
100-1370 SONY PLACE SE DECISION MADE: 18-JUL-13
WINNIPEG, MB CA R3T 1N5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
BIO COMPRESSION SYSTEMS, INC. 510(k) NO: K131327(TRADITIONAL)
ATTN: MAUREEN GARNER PHONE NO : 732 779 7422
1983 HAZELWOOD ROAD SE DECISION MADE: 18-JUL-13
TOMS RIVER NJ 08753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERTUS 140 CERTUSURGGT SURGICAL TOOL
NEUWAVE MEDICAL, INC. 510(k) NO: K130399(TRADITIONAL)
ATTN: DAN KOSEDNAR PHONE NO : 608 512 1592
3529 Anderson St SE DECISION MADE: 18-JUL-13
Madison WI 53704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)
VENOUS HEALTH SYSTEMS, INC. 510(k) NO: K131046(TRADITIONAL)
ATTN: RICH LAGUNA PHONE NO : 650 646 3327
3270 Alpine Rd SE DECISION MADE: 18-JUL-13
Portola Valley CA 94028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAOMI-CT
LK CONSULTING GROUP 510(k) NO: K123332(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
1515 E KATELLA AVE. UNIT 2115 SE DECISION MADE: 18-JUL-13
ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
GENORAY CO., LTD. 510(k) NO: K130088(TRADITIONAL)
ATTN: JAE KIM PHONE NO : 855 436 6729
1073 N, BATAVIA ST SE DECISION MADE: 18-JUL-13
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
NEOSURGICAL LTD 510(k) NO: K131688(SPECIAL)
ATTN: ORLA BRENNAN PHONE NO : 353 914210 00
BLOCK 12 GALWAY TECHNOLOGY PARK, PSE DECISION MADE: 18-JUL-13
GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLID GEL PAD
BLUEMTECH 510(k) NO: K131905(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
1515 E KATELLA AVE UNIT 2115 SE DECISION MADE: 18-JUL-13
ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
RANDOX LABORATORIES, LTD. 510(k) NO: K131776(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 028 944224 13
55 DIAMOND RD. SE DECISION MADE: 18-JUL-13
CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INPULSE LASER
INCISIVE INC. 510(k) NO: K131805(SPECIAL)
ATTN: KATHY MAYNOR PHONE NO : 352 586 3113
26 REBECCA CT SE DECISION MADE: 18-JUL-13
HOMOSASSA FL 34446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
JVC KENWOOD CORPORATION 510(k) NO: K131137(TRADITIONAL)
ATTN: TSUKASA TASHIRO PHONE NO : 81 258246 611
300-OYA UEDA-SHI SE DECISION MADE: 18-JUL-13
NAGANO-KEN JA 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
CARDIOSOLUTIONS INC 510(k) NO: K131332(SPECIAL)
ATTN: MICHELE LUCE PHONE NO : 781 344 0801
375 WEST STREET SE DECISION MADE: 19-JUL-13
MASSACHUSETTS MA 02379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLOCKNER DENTAL IMPLANT ABUTMENTS
SOADCO, S.L. 510(k) NO: K122988(ABBREVIATED)
ATTN: MARIA MITJANETA PHONE NO : 376 80 0599
AV FITER I ROSSELL 4 BIS LOCAL 2 SE DECISION MADE: 19-JUL-13
ESCALDES-ENGORDANY AN AD-700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IHEALTH CLOUD
ANDON HEALTH CO., LTD 510(k) NO: K131203(TRADITIONAL)
ATTN: YI LIU PHONE NO : 86 22 60526161
NO. 3 JINPING ROAD,YA’ AN STREET SE DECISION MADE: 19-JUL-13
TIANJIN CH 300193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
TECHNOMED EUROPE 510(k) NO: K130136(TRADITIONAL)
ATTN: PIERRE VREULS PHONE NO : 31 43 4086868
AMERIKALAAN 71 SE DECISION MADE: 19-JUL-13
MAASTRICHT AIRPORT NL 6199 AE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
ESSEX INDUSTRIES, INC. D/B/A ESSEX510(k) NO: K130068(TRADITIONAL)
ATTN: KEN SEISE PHONE NO : 314 338 8533
8007 CHIVVIS DRIVE SE DECISION MADE: 19-JUL-13
ST. LOUIS MO 63123 2395 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
REFLECTANCE MEDICAL INC 510(k) NO: K130079(TRADITIONAL)
ATTN: NANDINI MURTHY PHONE NO : 781 710 5378
116 FLAUNDERS ROAD, SUITE 1000 SE DECISION MADE: 19-JUL-13
WESTBOROUGH MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIXBO PM545
XBO MEDICAL SYSTEMS CO., LTD 510(k) NO: K130658(TRADITIONAL)
ATTN: JINHONG GUO PHONE NO : 86 316 2596056
INDUSTRIAL PK, RARE EARTH HI-TECH SE DECISION MADE: 19-JUL-13
MONGOLIA CH 014030 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TRANSCEND
SYNERON MEDICAL LTD. 510(k) NO: K120510(TRADITIONAL)
ATTN: SAM WADE PHONE NO : 972 543 303402
INDUSTRIAL ZONE, TAVOR BUILDING, PSE DECISION MADE: 19-JUL-13
YOKNEAM ILLIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATION PIN
EVERGREEN ORTHOPEDIC RESEARCH LAB 510(k) NO: K131130(TRADITIONAL)
ATTN: JEFF STEPHANIAN PHONE NO : 425 284 7262
11321 NE 120TH ST SE DECISION MADE: 19-JUL-13
KIRKLAND WA 98034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STABILIZ FIXATION SYSTEM – SPL LOCKING SCREW
STABILIZ ORTHOPAEDICS, LLC 510(k) NO: K130731(TRADITIONAL)
ATTN: DOUGLAS L CERYNIK, MD PHONE NO : 610 458 8555
665 STOCKTON DRIVE SE DECISION MADE: 19-JUL-13
EXTON PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T1040 AKA AURAWAVE
ENDURANCE THERAPEUTICS 510(k) NO: K124055(TRADITIONAL)
ATTN: BRAD BREZDEN PHONE NO : 866 854 2342
122B – FIRST STREET NE SE DECISION MADE: 19-JUL-13
DAUPHIN, MANITOBA CA R7N 1B5 510(k) STATEMENT
DEVICE: IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
BIO COMPRESSION SYSTEMS, INC. 510(k) NO: K131306(TRADITIONAL)
ATTN: MAUREEN GARNER PHONE NO : 732 779 7422
1983 HAZELWOOD ROAD SE DECISION MADE: 22-JUL-13
TOMS RIVER NJ 08753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K131191(TRADITIONAL)
ATTN: SUSAN KAGAN PHONE NO : 508 880 8097
325 PARAMOUNT DR. SE DECISION MADE: 22-JUL-13
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHYTHMIA MAPPING SYSTEM
RHYTHMIA MEDICAL, INC 510(k) NO: K130750(TRADITIONAL)
ATTN: LEON AMARIGLIO PHONE NO : 617 591 9191
111 SOUTH BEDFORD ST SUITE 205 SE DECISION MADE: 22-JUL-13
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR CONDITIONAL PRESSON ELECTRODE
RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K130220(TRADITIONAL)
ATTN: JAMES M MEWBORNE PHONE NO : 803 252 1222
1140 FIRST STREET SOUTH SE DECISION MADE: 22-JUL-13
COLUMBIA SC 29209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO AMBULATORY ECG RECORDER
DIMETEK DIGITAL MEDICAL TECHNOLOGI510(k) NO: K131572(TRADITIONAL)
ATTN: JIMMY GUAN PHONE NO : 86 755 88855978
3/F-A2, UNIT 8, XING HUA BUILDING,SE DECISION MADE: 22-JUL-13
SHEKOU, SHENZHEN CH 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SORIN "CONNECT DATA MANAGEMENT SYSTEM"
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K131816(TRADITIONAL)
ATTN: RENATE GOEBERT PHONE NO : 498 89 323010
LINDBERGH STRASSE 25 SE DECISION MADE: 23-JUL-13
MUNCHEN GM 80939 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
DENTSPLY INTL., INC. 510(k) NO: K130862(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717 849 4229
221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 23-JUL-13
YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPSCAN
MEDICAL ENGINEERING DEVELOPMENT SO510(k) NO: K123807(TRADITIONAL)
ATTN: TIM CORESSEL PHONE NO : 303 452 0484
11060 IRMA DRIVE SE DECISION MADE: 23-JUL-13
NORTHGLENN CO 80233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRAG-LOC SYSTEM
ACUMED LLC 510(k) NO: K130986(TRADITIONAL)
ATTN: KARA BUDOR PHONE NO : 503 207 1412
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 23-JUL-13
HILLSBORO OR 97124 9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORUM GLAUCOMA WORKPLACE
CARL ZEISS MEDITEC AG 510(k) NO: K130648(TRADITIONAL)
ATTN: MANDY AMBRECHT PHONE NO : 925 557 4561
5160 HACIENDA DRIVE SE DECISION MADE: 23-JUL-13
DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIGHTINGALE MONITORING SYSTEM
ZOE MEDICAL, INC. 510(k) NO: K130740(TRADITIONAL)
ATTN: JAMES CHICKERING PHONE NO : 978 887 1410
460 BOSTON ST. SE DECISION MADE: 23-JUL-13
TOPSFIELD MA 01983 1223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS HEALTHCARE CARDIOEXPRESS
SPACELABS HEALTHCARE LTD. 510(k) NO: K130207(TRADITIONAL)
ATTN: THOMAS KROENKE PHONE NO : 303 956 4232
PO BOX 3018 SE DECISION MADE: 23-JUL-13
NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRSONETT AIR-4
AIRSONETT, AB 510(k) NO: K130702(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976
435 RICE CREEK TERRACE NE SE DECISION MADE: 23-JUL-13
FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAEXTEND USWS-900A V2.1 AND V3.1
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K131822(TRADITIONAL)
ATTN: PHONE NO :
2441 MICHELLE DR. SE DECISION MADE: 23-JUL-13
TUSTIN CA 92780 2068 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MFP-051
GC AMERICA, INC. 510(k) NO: K123631(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 597 0900
3737 WEST 127TH ST. SE DECISION MADE: 23-JUL-13
ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESIE APPS SUITE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132062(TRADITIONAL)
ATTN: PATRICK J LYNCH PHONE NO : 650 694 5658
685 EAST MIDDLEFIELD ROAD SE DECISION MADE: 23-JUL-13
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MTA CEMENTS
S&C POLYMER SILICON- UND COMPOSITE510(k) NO: K130125(TRADITIONAL)
ATTN: CHRISTIAN BOETTCHER PHONE NO : 49 4121 4830
ROBERT-BOSCH-STRASSE 2 SE DECISION MADE: 24-JUL-13
ELMSHORN, SCHLESWIG-HOLSTEIN GM510(k) STATEMENT
DEVICE: POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
PREVENTIVE CARE, INC. 510(k) NO: K130667(TRADITIONAL)
ATTN: ANIL SEGAT PHONE NO : 651 322 9120
15215 BOULDER TRAIL SE DECISION MADE: 24-JUL-13
ROSEMOUNT MN 55068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
LINA MEDICAL APS 510(k) NO: K130305(TRADITIONAL)
ATTN: RICHARD GILLIS PHONE NO : 512 327 9997
611 WEST 5TH STRRET THIRD FLOOR SE DECISION MADE: 24-JUL-13
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS EMBOL-X INTRODUCER SHEATH
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K123714(TRADITIONAL)
ATTN: LUKE MEIDELL PHONE NO : 801 565 6212
12050 LONE PEAK PKWY SE DECISION MADE: 24-JUL-13
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPERGUIDE
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K131263(ABBREVIATED)
ATTN: JOS V VROONHOVEN PHONE NO : 310 402794 221
VEENPLUIS 4-6 SE DECISION MADE: 24-JUL-13
BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAM JUNCTIONAL TOURNIQUET
SAM MEDICAL PRODUCTS 510(k) NO: K131561(TRADITIONAL)
ATTN: JACK N MCCUTCHEON PHONE NO : 503 639 5474
27350 SW 95TH AVE STE 3038 SE DECISION MADE: 24-JUL-13
Wilsonville OR 97070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFORM PEDICLE SCREW SYSTEM
SPINAL USA 510(k) NO: K131343(TRADITIONAL)
ATTN: MEREDITH MAY PHONE NO : 719 337 7579
4628 NORTHPARK DRIVE SE DECISION MADE: 24-JUL-13
COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMATOLOGY QUALITY CONTROL MIXTURE
R & D SYSTEMS, INC. 510(k) NO: K130962(SPECIAL)
ATTN: AMBREEN ATHAR PHONE NO : 612 379 2956
614 MCKINLEY PL., N.E. SE DECISION MADE: 24-JUL-13
MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K131690(SPECIAL)
ATTN: YANG ZHAOHUI PHONE NO : 86 755 81885640
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 24-JUL-13
SHENZHEN, GUANGDONG CH 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
NOVABAY PHARMACEUTICALS, INC 510(k) NO: K131542(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301 652 5344
5600 WISCONSIN AVENUE # 509 SE DECISION MADE: 24-JUL-13
CHEVY CHASE MD 20815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
MEDTRONIC INC. 510(k) NO: K131964(SPECIAL)
ATTN: LISA STONE PHONE NO : 763 514 9866
8200 CORAL SEA STREET NE SE DECISION MADE: 24-JUL-13
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEM-6131
OMRON HEALTHCARE, INC. 510(k) NO: K131742(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 24-JUL-13
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERCUNAV SYSTEM
PHILIPS HEALTHCARE 510(k) NO: K132087(TRADITIONAL)
ATTN: DAVE SZCZUPAKOWSKI PHONE NO :
49 SPADINA AVENUE #310 SE DECISION MADE: 24-JUL-13
TORONTO CA M5V 2J1 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DUOFLEX COIL SUITE (1.5T)
MR INSTRUMENTS, INC. 510(k) NO: K130706(TRADITIONAL)
ATTN: ROBERT BECK PHONE NO : 952 746 1435
5610 ROWLAND RD. SUITE 145 SE DECISION MADE: 25-JUL-13
MINNEAPOLIS MN 54343 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HAMMERTOE CORRECTION SYSTEM
ARTHROSURFACE, INC. 510(k) NO: K130859(TRADITIONAL)
ATTN: DAWN J WILSON PHONE NO : 508 520 3003
28 FORGE PARKWAY SE DECISION MADE: 25-JUL-13
FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTRELIEF
CHATTEM, INC. 510(k) NO: K131159(TRADITIONAL)
ATTN: ERIC JOSEPH PHONE NO : 423 822 3268
1715 WEST 38TH ST. SE DECISION MADE: 25-JUL-13
CHATTANOOGA TN 37409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPRESSYN BAND
DALLEN MEDICAL, INC. 510(k) NO: K130431(TRADITIONAL)
ATTN: AL MEMMOLO PHONE NO : 949 218 0030
1046 Calle Recodo Ste G SE DECISION MADE: 25-JUL-13
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-SCAN
BIO-RESEARCH ASSOCIATES, INC. 510(k) NO: K130158(TRADITIONAL)
ATTN: JOHN RADKE PHONE NO : 414 357 7525
9275 NORTH 49TH STREET SUITE 150 SE DECISION MADE: 25-JUL-13
BROWN DEER WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPSTONE(R) SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K123027(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901 344 0807
1800 PYRAMID PLACE SE DECISION MADE: 25-JUL-13
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JONES-FX FRACTURE SYSTEM
INSTRATEK, INC. 510(k) NO: K131620(TRADITIONAL)
ATTN: JEFF SEAVEY PHONE NO : 281 890 8020
4141 Directors Row Ste H SE DECISION MADE: 25-JUL-13
Houston TX 77092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K131974(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508 828 3359
325 PARAMOUNT DR. SE DECISION MADE: 25-JUL-13
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSIS, SENSIS LITE
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K131812(SPECIAL)
ATTN: PATRICIA D JONES PHONE NO : 610 448 3536
51 VALLEY STREAM PARKWAY SE DECISION MADE: 25-JUL-13
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQQA-LIVER MULTIMODALITY SOFTWARE
EDDA TECHNOLOGY, INC. 510(k) NO: K131498(TRADITIONAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
5 Independence Way SE DECISION MADE: 25-JUL-13
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRICADE EMBOLIZATION COIL SYSTEM
BLOCKADE MEDICAL 510(k) NO: K131475(SPECIAL)
ATTN: REBECCA K PINE PHONE NO : 760 809 5178
18 Technology Dr Ste 169 SE DECISION MADE: 25-JUL-13
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARE SU01A SUCTION ASPIRATOR
FOSHAN CARE MEDICAL TECHNOLOGY CO.510(k) NO: K130001(TRADITIONAL)
ATTN: GANG WU PHONE NO : 867 578802 3265
THE 2F AND 3F, G BUILDING, NO.1 HUSE DECISION MADE: 25-JUL-13
FOSHAN, GUANGDONG CH 528000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VDRIVE W/V-SONO
STEREOTAXIS, INC. 510(k) NO: K122659(TRADITIONAL)
ATTN: HORWITZ PHONE NO :
4320 FOREST PARK AVENUE SUITE 100 SE DECISION MADE: 26-JUL-13
ST. LOUIS MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
STERIS CORPORATION 510(k) NO: K123768(TRADITIONAL)
ATTN: MARCIA L BENEDICT PHONE NO : 440 392 7063
5960 HEISLEY ROAD SE DECISION MADE: 26-JUL-13
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK REVISION EXTENSION
MEDACTA INTERNATIONAL 510(k) NO: K123721(TRADITIONAL)
ATTN: ADAM GROSS PHONE NO : 805 437 7085
4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 26-JUL-13
CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRX CHANNEL RFA ENDOSCOPIC CATHETER
COVIDIEN LLC 510(k) NO: K130623(TRADITIONAL)
ATTN: RICHELLE HOVER PHONE NO : 408 328 7342
15 HAMPSHIRE ST SE DECISION MADE: 26-JUL-13
MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
DENTSOLL, INC. 510(k) NO: K130680(TRADITIONAL)
ATTN: DAVID C FURR PHONE NO : 512 906 9654
8708 CAPEHART COVE SE DECISION MADE: 26-JUL-13
AUSTIN TX 78733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
GLOBE MEDICAL, INC. 510(k) NO: K130478(TRADITIONAL)
ATTN: SARAH MARIE FITZGERALD PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 26-JUL-13
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL UNIT WITH CHAIR
XIANYANG NORTH WEST MEDICAL INSTRU510(k) NO: K130410(SPECIAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 237-023 SE DECISION MADE: 26-JUL-13
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TETRACHROME REAGENTS AND TETRACXP SYSTEM
BECKMAN COULTER, INC. 510(k) NO: K121445(SPECIAL)
ATTN: NANCY NADLER PHONE NO : 305 380 4191
11800 SW 147TH AVE. M/S 31-B06 SE DECISION MADE: 26-JUL-13
MIAMI FL 33196 2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEER 1000
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K130785(SPECIAL)
ATTN: BERT SCHADOW PHONE NO : 493 328394 270
ODERSTRASSE 77 SE DECISION MADE: 26-JUL-13
TELTOW GM 14513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
GEBR. BRASSELER GMBH & CO. KG 510(k) NO: K131264(TRADITIONAL)
ATTN: ERELA DANA PHONE NO : 202 552 5800
1331 H STREET NW 12TH FLOOR SE DECISION MADE: 26-JUL-13
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K130331(TRADITIONAL)
ATTN: CHRISTOPHER SMEJKAL PHONE NO : 44 208 3224200
49-53 YORK ST. SE DECISION MADE: 26-JUL-13
TWICKENHAM, MIDDLESEX UK TW1-3L510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIRMON SERIES
KUWOTECH CO., LTD 510(k) NO: K131117(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
1515 E KATELLA AVE UNIT 2115 SE DECISION MADE: 26-JUL-13
ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
KOELIS 510(k) NO: K131448(TRADITIONAL)
ATTN: LAETITIA GERVAIS PHONE NO : 334 766375 87
5 AVENUE DU GRAND SABLON SE DECISION MADE: 26-JUL-13
LA TRONCHE FR 38700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HBA1C CONTROL, LEVEL 1 AND LEVEL 2
RANDOX LABORATORIES, LTD. 510(k) NO: K131999(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 028 944224 13
55 DIAMOND RD. SE DECISION MADE: 26-JUL-13
CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEMOLOCK, CHEMOLOCK PORT
ICU MEDICAL INC 510(k) NO: K131549(TRADITIONAL)
ATTN: KATHERINE KENNER PHONE NO : 801 264 1702
4455 ATHERTON DRIVE SE DECISION MADE: 26-JUL-13
SALT LAKE CITY UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
EUROTROL B.V. 510(k) NO: K131595(TRADITIONAL)
ATTN: PAUL KOOIJMANS PHONE NO : 31 318 695777
KEPLERLAAN 20 SE DECISION MADE: 26-JUL-13
EDE NL NL 6716 BS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
IBI ISRAEL BIOMEDICAL INNOVATIONS 510(k) NO: K130059(TRADITIONAL)
ATTN: ELISSA BURG PHONE NO : 972 462771 66107
1914 J.N. PEASE PLACE SE DECISION MADE: 29-JUL-13
CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
COVIDIEN 510(k) NO: K131361(TRADITIONAL)
ATTN: STACEY A STRAND PHONE NO : 303 305 2631
6135 GUNBARREL AVE. SE DECISION MADE: 29-JUL-13
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET ULTRA POWER PULSE KIT
MEDRAD, INC. 510(k) NO: K130381(TRADITIONAL)
ATTN: AMRA RACIC PHONE NO : 763 450 8500
9055 EVERGREEN BLVD NW SE DECISION MADE: 29-JUL-13
MINNEAPOLIS MN 55433 8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPHTACATH KIT
FRANCE CHIRURGAE INSTRUMENTATION 510(k) NO: K123831(TRADITIONAL)
ATTN: BARBARA S FANT PHONE NO : 513 961 8200
3308 JEFFERSON AVE UPPER LEVEL SE DECISION MADE: 29-JUL-13
CINCINNATI OH 45220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIFIX S KNOTLESS FIXATION DEVICE
ARTHOCARE CORPORATION 510(k) NO: K131182(TRADITIONAL)
ATTN: MITCHELL DHORITY PHONE NO : 512 358 5995
7000 WEST WILLIAM CANNON DRIVE SE DECISION MADE: 29-JUL-13
AUSTIN TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTFE SUPER SHEATH INTRODUCER
MARTECH MEDICAL PRODUCTS 510(k) NO: K130855(TRADITIONAL)
ATTN: ALEXIS ERAZO PHONE NO : 215 256 4201
1500 DELP DR. SE DECISION MADE: 29-JUL-13
HARLEYSVILLE PA 19438 2900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT HYDROPHILIC GUIDE WIRE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K131710(SPECIAL)
ATTN: MARTHA FOLAN PHONE NO : 353 91 703700
PARKMORE BUSINESS PARK WEST SE DECISION MADE: 29-JUL-13
GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
CELLO PARTNERSHIP D/B/A VERIZON WI510(k) NO: K122458(TRADITIONAL)
ATTN: CARLOS GONZALEZ PHONE NO : 952 209 6605
ONE VERIZON WAY SE DECISION MADE: 30-JUL-13
BASKING RIDGE NJ 07920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BROADMASTER HEALTHCARE SYSTEM
BROADMASTER BIOTECH CORPORATION 510(k) NO: K130621(TRADITIONAL)
ATTN: ROGER LAI PHONE NO : 886 987111 105
7F, NO. 168-2, LIANCHENG SE DECISION MADE: 30-JUL-13
ZHONGHE CITY TW 23553 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
SPINEVISION, S.A. 510(k) NO: K130302(SPECIAL)
ATTN: HELENE PLAS PHONE NO : 33 153 332525
ANTONY PARC II – 10 PLACE DU GENERSE DECISION MADE: 30-JUL-13
ANTONY CEDEX FR 92184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDAPPS 2.0 – REMOTE PATIENT MONITORING SYSTEM
MEDAPPS INC., DBA ALERE CONNECT 510(k) NO: K124000(TRADITIONAL)
ATTN: KENT DICKS PHONE NO : 480 305 6323
8767 E. VIA DE VENTURA, STE 300 SE DECISION MADE: 30-JUL-13
SCOTTSDALE AZ 85258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURA COMPENSATOR
CURA MEDICAL TECHNOLOGIES, LLC 510(k) NO: K131150(TRADITIONAL)
ATTN: THOMAS H FARIS PHONE NO : 650 996 1192
23 RANCHO CIRCLE SE DECISION MADE: 30-JUL-13
LAKE FOREST CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COALITION SPACER
GLOBUS MEDICAL, INC. 510(k) NO: K131449(TRADITIONAL)
ATTN: CHRISTINA KICHULA PHONE NO : 610 930 1800
2560 General Armistead Ave VALLEY SE DECISION MADE: 30-JUL-13
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROBLATE(TM) SYSTEM
MONTERIS MEDICAL, INC. 510(k) NO: K131955(SPECIAL)
ATTN: CRAIG COOMBS PHONE NO : 510 337 0140
1193 SHERMAN ST SE DECISION MADE: 30-JUL-13
ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
MEDTRONIC INC. 510(k) NO: K132008(SPECIAL)
ATTN: MICHELE MACHACEK PHONE NO : 763 526 2382
8200 CORAL SEA STREET SE DECISION MADE: 30-JUL-13
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABL90 FLEX
RADIOMETER MEDICAL APS 510(k) NO: K130144(SPECIAL)
ATTN: MARTIN GABLER PHONE NO : 45 3827 3114
AKANDEVEJ 21 SE DECISION MADE: 31-JUL-13
BRONSHOJ DA DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5F DIGNITY CT TITANIUM PORT
MEDICAL COMPONENTS INC 510(k) NO: K130923(TRADITIONAL)
ATTN: SARAH SHAFFER PHONE NO : 215 256 4201
1499 DELP DRIVE SE DECISION MADE: 31-JUL-13
HARLEYSVILLE PA 19438 510(k) STATEMENT
DEVICE: OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
MATRIX SURGICAL USA 510(k) NO: K123908(TRADITIONAL)
ATTN: JULIE STEPHENS PHONE NO : 678 513 0465
111 LAUREL RIDGE DRIVE SE DECISION MADE: 31-JUL-13
ALPHARETTA GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMI PICC III CATHETER, NMI HPICC III CATHETER
NAVILYST MEDICAL, INC. 510(k) NO: K131942(SPECIAL)
ATTN: LORRAINE M HANLEY PHONE NO : 508 658 7945
26 FOREST STREET SE DECISION MADE: 31-JUL-13
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIAL CONNECTOR 13MM CLOSED COLLAR
MEDIMOP MEDICAL PROJECTS, LTD. 510(k) NO: K132040(SPECIAL)
ATTN: ILANIT GOLDGRABER PHONE NO : 972 9 7778666
17 HATIDHAR ST. SE DECISION MADE: 31-JUL-13
RA’ANANA IS 4366519 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX SPEEDCINCH
ARTHREX, INC. 510(k) NO: K132043(SPECIAL)
ATTN: LEON BROWN II, PH.D. PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 31-JUL-13
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REXTAR X
META BIOMED, INC. 510(k) NO: K132041(SPECIAL)
ATTN: BLIX WINSTON PHONE NO : 301 601 9185
2600 MULLINIX MILL ROAD SE DECISION MADE: 31-JUL-13
MT. AIRY MD 21771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
AMECO MEDICAL INDUSTRIES 510(k) NO: K131814(SPECIAL)
ATTN: RAY KELLY PHONE NO : 203 400 7566
57 LAZY BROOK RD. SE DECISION MADE: 26-JUL-13
MONROE CT 03468 510(k) STATEMENT
DEVICE: COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
COOK, INC. 510(k) NO: K122091(TRADITIONAL)
ATTN: SEAN SPENCE PHONE NO : 812 339 2235
750 DANIELS WAY SE DECISION MADE: 29-JUL-13
Blmgtn IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
