SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JUL-2008 THROUGH 31-JUL-2008 DEVICE: ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.0 AB BIODISK 510(k) NO: K081325(TRADITIONAL)
ATTN: ANETTE ENGELHARDT PHONE NO : 460 873 00760 DALVAGEN 10 SE DECISION MADE: 24-JUL-08 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTIO ABBOTT MOLECULAR, INC. 510(k) NO: K080739(TRADITIONAL)
ATTN: PAULA E MARTIN PHONE NO : 224-361-7333 1300 EAST TOUHY AVENUE SE DECISION MADE: 10-JUL-08 DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER WORKS DOUCHING DEVICE ABBOTT RESEARCH GROUP, INC. 510(k) NO: K080200(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 10-JUL-08 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCIN BIPOLAR HEAD SYSTEM ACCELERATED INNOVATION, LLC 510(k) NO: K080647(TRADITIONAL)
ATTN: MICHAEL KVITMITSKY PHONE NO : 973-777-8832 1033 US HIGHWAY 46 EAST SE DECISION MADE: 08-JUL-08 SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA CLIFTON, NJ 07013 DEVICE: ACTITRAINER ACTIGRAPH, LLC 510(k) NO: K080545(TRADITIONAL)
ATTN: JOHN SCHEIDER PHONE NO : 850-332-7900 15 W. MAIN. ST SE DECISION MADE: 24-JUL-08 PENSACOLA, FL 32502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CINCH ANCHOR, MODEL 1194 ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K081208(TRADITIONAL)
ATTN: PENNY HOUSTON PHONE NO : 972-309-8000 6901 PRESTON RD. SE DECISION MADE: 18-JUL-08 PLANO, TX 75024 510(k) STATEMENT DEVICE: MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION S AFFYMETRIX, INC. 510(k) NO: K080995(TRADITIONAL)
ATTN: MAUREEN J MENDE PHONE NO : 916-376-1309 3420 CENTRAL EXPRESSWAY SE DECISION MADE: 30-JUL-08 SANTA CLARA, CA 95051 510(k) STATEMENT DEVICE: MODIFICATION TO MAMMAPRINT AGENDIA BV 510(k) NO: K080252(TRADITIONAL)
ATTN: GUIDO BRINK PHONE NO : 31 20 5129161 LOUWESWEG 6 SE DECISION MADE: 21-JUL-08 AMSTERDAM, NETHERLANDS 1066 EC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS AGFA HEALTHCARE CORPORATION 510(k) NO: K081963(TRADITIONAL)
ATTN: JEFFERY A JEDLICKA PHONE NO : 864-421-1815 10 SOUTH ACADEMY STREET SE DECISION MADE: 25-JUL-08 GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION AGFA HEALTHCARE CORPORATION 510(k) NO: K081976(TRADITIONAL)
ATTN: PHONE NO : 10 SOUTH ACADEMY STREET SE DECISION MADE: 28-JUL-08 GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: S40 CLINICAL ANALYZER, S TEST ALB ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K072143(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158 4 HENDERSON DRIVE SE DECISION MADE: 14-JUL-08 WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAGUNA SIZE 8 PEDICLE SCREW ALLEZ SPINE, LLC 510(k) NO: K072678(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 619-885-7733 2301 DUPONT DRIVE, SUITE 510 SE DECISION MADE: 02-JUL-08 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCES ALMA LASERS LTD. 510(k) NO: K080463(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200 3637 BERNAL AVE. SE DECISION MADE: 23-JUL-08 PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 ALOKA CO., LTD. 510(k) NO: K081843(TRADITIONAL)
ATTN: RICHARD CEHOVSKY PHONE NO : 800-872-5652 10 FAIRFIELD BLVD. SE DECISION MADE: 15-JUL-08 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZODIC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K081158(SPECIAL)
ATTN: MARY STANNERS PHONE NO : 760-494-6771 2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 03-JUL-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92011 DEVICE: AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 AMDL, INC. 510(k) NO: K072901(TRADITIONAL)
ATTN: GARY DREHER PHONE NO : 714-505-4461 2492 WALNUT AVE. SUITE 100 SE DECISION MADE: 01-JUL-08 TUSTIN, CA 92780-7039 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER AMPLIVOX, LTD. 510(k) NO: K081841(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-8854 P.O. BOX 7007 SE DECISION MADE: 16-JUL-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LIASYS WITH MODELS LIASYS AMS S.R.L. ANALYZER MEDICAL SYSTEM510(k) NO: K080468(TRADITIONAL)
ATTN: STEFANO CORRADI PHONE NO : 390 774 354441 17/A VIA E. BARSANTI SE DECISION MADE: 25-JUL-08 GUIDONIA (ROME), ITALY I-00012 510(k) STATEMENT DEVICE: AG-605 BLOOD GLUCOSE MONITORING SYSTEM ANDON HEALTH CO.,LTD 510(k) NO: K073030(TRADITIONAL)
ATTN: MS. MONA PHONE NO : 86 22 60526161 YA AN RD NANKAI DISTRICT SE DECISION MADE: 21-JUL-08 TIAJIN, CHINA 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD 510(k) NO: K080319(TRADITIONAL)
ATTN: MS. MONA PHONE NO : 862 260 526161 NO. 10 JINPING ROAD SE DECISION MADE: 02-JUL-08 YAAN ROAD NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA TIAJIN, CHINA 300190 DEVICE: KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD 510(k) NO: K080326(TRADITIONAL)
ATTN: PHONE NO : NO. 10 JINPING ROAD SE DECISION MADE: 31-JUL-08 YAAN ROAD NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA TIAJIN, CHINA 300190 DEVICE: ONCOBIONIC BIPOLAR ELECTRODE ANGIODYNAMICS, INC. 510(k) NO: K080287(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 03-JUL-08 QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIBLATE ELECTROSURGICAL DEVICE ANGIODYNAMICS, INC. 510(k) NO: K080451(TRADITIONAL)
ATTN: BRIAN KUNST PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 03-JUL-08 QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES APPASAMY ASSOCIATES 510(k) NO: K082031(TRADITIONAL)
ATTN: R.N. KASTHURI PHONE NO : 91 044 32980153 20, SBI OFFICERS COLONY SE DECISION MADE: 31-JUL-08 1ST STREET 510(k) SUMMARY AVAILABLE FROM FDA ARUMBAKKAM, CHENNAI, INDIA 600 106THIRD PARTY REVIEW DEVICE: INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFIL ART OPTICAL CONTACT LENS, INC. 510(k) NO: K073621(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490 806 KIMBALL AVENUE SE DECISION MADE: 03-JUL-08 GRAND JUNCTION, CO 81501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGN ARTHROCARE CORP. 510(k) NO: K081497(SPECIAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-585-2406 15285 ALTON PARKWAY, #200 SE DECISION MADE: 28-JUL-08 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED MASIMO PULSE OXIMETER SENSORS ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K081238(TRADITIONAL)
ATTN: KATIE BRAY PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 29-JUL-08 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETERS ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K081329(TRADITIONAL)
ATTN: KATIE BRAY PHONE NO : 480-763-5386 10232 SOUTH 51ST ST. SE DECISION MADE: 09-JUL-08 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPRESS CHEST DRAIN ATRIUM MEDICAL CORP. 510(k) NO: K081718(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 25-JUL-08 HUDSON, NH 03051 510(k) STATEMENT DEVICE: BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY G B-K MEDICAL APS 510(k) NO: K081323(TRADITIONAL)
ATTN: JENS RASMUSSEN PHONE NO : 011 45 44528100 MILEPARKEN 34 SE DECISION MADE: 22-JUL-08 HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIRTHTRACK BARNEV, LTD. 510(k) NO: K080672(SPECIAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA'AS ST. SE DECISION MADE: 08-JUL-08 KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 BECTON DICKINSON & CO. 510(k) NO: K081446(ABBREVIATED)
ATTN: PASQUALE AMATO PHONE NO : 201-847-4513 1 BECTON DRIVE SE DECISION MADE: 17-JUL-08 FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRIST PULSE OXIMETER MD300W BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K081125(SPECIAL)
ATTN: LEI WANG PHONE NO : 86 108 8790480 ROOM 1127-1128 BUILDING B SE DECISION MADE: 02-JUL-08 BAILANGYUAN FUXING RD. #A36 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, CHINA 100041 DEVICE: GENEX PUTTY BIOCOMPOSITES LTD. 510(k) NO: K073341(TRADITIONAL)
ATTN: SIMON FITZER PHONE NO : 44 1 782338580 KEELE SCIENCE PARK SE DECISION MADE: 09-JUL-08 KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 BIOLITEC, INC. 510(k) NO: K081015(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST., NW SE DECISION MADE: 08-JUL-08 WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAM STRUCTSURE PRECISION MILLED BARS BIOMET 3I, INC. 510(k) NO: K080864(TRADITIONAL)
ATTN: TAMARA WEST PHONE NO : 561-776-6923 4555 RIVERSIDE DR. SE DECISION MADE: 21-JUL-08 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAESTRO WRIST FRACTURE IMPLANT BIOMET MANUFACTURING CORP. 510(k) NO: K080426(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 29-JUL-08 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: COMPOSITE HITCH SUTURE ANCHOR BIOMET MANUFACTURING CORP. 510(k) NO: K081172(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639 PO BOX 587 SE DECISION MADE: 17-JUL-08 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLITAIRE ANTERIOR SPINAL SYSTEM BIOMET SPINE 510(k) NO: K081501(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973-299-9300 100 INTERPACE PARKWAY SE DECISION MADE: 02-JUL-08 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS BIOMET TRAUMA 510(k) NO: K081244(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 30-JUL-08 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPREHENSIVE REVERSE SHOULDER BIOMET, INC. 510(k) NO: K080642(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 09-JUL-08 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK BIONOSTICS, INC. 510(k) NO: K081403(TRADITIONAL)
ATTN: RANDY BYRD PHONE NO : 978-772-7070 7 JACKSON RD. SE DECISION MADE: 25-JUL-08 DEVENS, MA 01434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K081177(TRADITIONAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838 1211 HAMBURG TURNPIKE SE DECISION MADE: 23-JUL-08 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA WAYNE, NJ 07470 DEVICE: STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CA BOSTON SCIENTIFIC CORP. 510(k) NO: K080982(TRADITIONAL)
ATTN: MARK MURPHY PHONE NO : 763-494-2377 2 SCIMED PLACE SE DECISION MADE: 14-JUL-08 MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEG LAPAROSCOPIC ELECTRODES BOVIE MEDICAL 510(k) NO: K081431(TRADITIONAL)
ATTN: RICHARD KOZLOFF PHONE NO : 727-803-8513 7100 30TH AVE. NORTH SE DECISION MADE: 24-JUL-08 ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING S BRAEMAR, INC. 510(k) NO: K081444(TRADITIONAL)
ATTN: DARREN DERSHEM PHONE NO : 651-286-8620 1285 CORPORATE CENTER DR. SE DECISION MADE: 31-JUL-08 SUITE 150 510(k) STATEMENT EAGAN, MN 55121 DEVICE: PORCINE SURGICAL MESH; DERMAL MATRIX BRENNEN MEDICAL, LLC 510(k) NO: K081272(TRADITIONAL)
ATTN: KENNETH B HERLAND PHONE NO : 651-429-7413 1290 HAMMOND RD. SE DECISION MADE: 31-JUL-08 ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUSSE PLASTIC LOR SYRINGE BUSSE HOSIPITAL DISPOSABLES 510(k) NO: K080804(SPECIAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711 75 ARKAY DR PO BOX 11067 SE DECISION MADE: 09-JUL-08 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN C.R. BARD, INC. 510(k) NO: K080668(SPECIAL)
ATTN: GENEVIEVE BALUTOWSKI PHONE NO : 480-303-2524 1625 WEST 3RD ST. SE DECISION MADE: 30-JUL-08 P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85281-1740 DEVICE: ASPIRA PERITONEAL DRAINAGE SYSTEM C.R. BARD, INC. 510(k) NO: K081288(TRADITIONAL)
ATTN: HENRY BOLAND PHONE NO : 801-595-0700 605 NORTH 5600 WEST SE DECISION MADE: 18-JUL-08 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUFRAME CAGENIX INC. 510(k) NO: K081157(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 22-JUL-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM, MOD CARESTREAM HEALTH,INC. 510(k) NO: K081836(SPECIAL)
ATTN: CHRISTINE EHMANN PHONE NO : 585-627-6473 150 VERONA STREET SE DECISION MADE: 30-JUL-08 ROCHESTER, NY 14608 510(k) STATEMENT DEVICE: COMBI 8 MAX CEC ELECTRONICA S.R.L. 510(k) NO: K070888(ABBREVIATED)
ATTN: BENNY ARAZY PHONE NO : 972 4 9940337 M.P. MIGAV 20187 SE DECISION MADE: 03-JUL-08 INDUSTRIAL PARK 13 510(k) SUMMARY AVAILABLE FROM FDA MIZPE AVIV, ISRAEL 20187 DEVICE: AOC SOLUBLE IMPLANT MATERIAL CEREMED, INC. 510(k) NO: K081531(TRADITIONAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 18-JUL-08 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOCHANNEL CHAD THERAPEUTICS, INC. 510(k) NO: K081176(TRADITIONAL)
ATTN: KEVIN MCCULLOH PHONE NO : 818-882-0883 21622 PLUMMER ST. SE DECISION MADE: 28-JUL-08 CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHROMOLITE EP CHROMOGENEX TECHNOLOGIES LIMITED 510(k) NO: K081619(SPECIAL)
ATTN: PETER R BEVAN PHONE NO : 441 554 784326 UNITS 1& 2 HEOL RHOSYN SE DECISION MADE: 18-JUL-08 PARC DAFEN 510(k) SUMMARY AVAILABLE FROM FDA LLANELLI, CARMARTHENSHIRE, UNITED KINGDOM SA14 8QG DEVICE: SAVI APPLICATOR KIT CIANNA MEDICAL, INC. 510(k) NO: K081677(SPECIAL)
ATTN: GARY MOCNIK PHONE NO : 949-360-0059 6 JOURNEY SE DECISION MADE: 22-JUL-08 SUITE 125 510(k) SUMMARY AVAILABLE FROM FDA ALISO VIEJO, CA 92656 DEVICE: LION SE ONE STEP ORTHODONTIC ADHESIVE CLASSONE ORTHODONTICS, INC. 510(k) NO: K080445(TRADITIONAL)
ATTN: JUDY RIBORDY PHONE NO : 806-797-1199 5064 50TH ST. SE DECISION MADE: 16-JUL-08 LUBBOCK, TX 79414 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. 510(k) NO: K080583(SPECIAL)
ATTN: LARAINE PANGELINA PHONE NO : 650-938-2100 301 E. EVELYN AVE. SE DECISION MADE: 18-JUL-08 MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR CONMED LINVATEC 510(k) NO: K072291(TRADITIONAL)
ATTN: JON WARD PHONE NO : 813-399-2855 11311 CONCEPT BOULEVARD SE DECISION MADE: 14-JUL-08 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS COOK, INC. 510(k) NO: K081113(TRADITIONAL)
ATTN: SUSANNE GALIN PHONE NO : 812-339-2235 750 DANIELS WAY SE DECISION MADE: 30-JUL-08 BLOOMINGTON, IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETE COOK, INC. 510(k) NO: K081690(SPECIAL)
ATTN: NATHAN SIMON PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 14-JUL-08 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VIS DADE BEHRING, INC. 510(k) NO: K081161(TRADITIONAL)
ATTN: HELEN M LEE PHONE NO : 302-631-8706 500 GBC DR, MAILSTOP 514 SE DECISION MADE: 28-JUL-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION V DADE BEHRING, INC. 510(k) NO: K081249(TRADITIONAL)
ATTN: ANNA MARIE KATHLEEN ENNIS PHONE NO : 302-631-9352 500 GBC DR, MAILSTOP 514 SE DECISION MADE: 21-JUL-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPIMAGE DANISH DIAGNOSTIC DEVELOPMENT A/S 510(k) NO: K081829(TRADITIONAL)
ATTN: NIELS SORENSEN PHONE NO : 45 45 768888 DR. NEERGAARDSVEJ 5F SE DECISION MADE: 11-JUL-08 HORSHOLM, DENMARK 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IMPROVED COMFORT-FIT NIGHTGUARD DENTEK ORAL CARE, INC. 510(k) NO: K081669(SPECIAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH STREET, NW SE DECISION MADE: 10-JUL-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K080991(TRADITIONAL)
ATTN: DAWN SINCLAIR PHONE NO : 574-372-5023 700 ORTHOPAEDIC DR. SE DECISION MADE: 02-JUL-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FABIUS MRI DRAEGER MEDICAL AG & CO. KG 510(k) NO: K072884(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 215-660-2078 3135 QUARRY ROAD SE DECISION MADE: 30-JUL-08 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRODE ARRAY CAP ELECTRODE ARRAYS 510(k) NO: K071446(ABBREVIATED)
ATTN: ELVIRA GARCIA PHONE NO : 915-760-5253 612 N. RESLER SE DECISION MADE: 02-JUL-08 EL PASO, TX 79912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE ELECTROMEDICS CO. LTD. 510(k) NO: K073616(TRADITIONAL)
ATTN: JOHN SCHOLZ PHONE NO : 201-935-0770 55 ANDERSON AVENUE SE DECISION MADE: 23-JUL-08 MOONACHIE, NJ 07074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDI ELEKTA NEUROMAG OY 510(k) NO: K081430(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 P.O. BOX 68 SE DECISION MADE: 28-JUL-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRE PRO, MODEL L2RY ELLEX MEDICAL PTY. LTD. 510(k) NO: K081565(SPECIAL)
ATTN: KEVIN HOWARD PHONE NO : 61 8 81045200 82 GILBERT ST. SE DECISION MADE: 02-JUL-08 ADELAIDE, SOUTH AUSTRALIA, AUSTRAL510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANCHORAGE SCOPE, MODEL 000003 EPITEK, INC. 510(k) NO: K080780(TRADITIONAL)
ATTN: WERNER HAMPL PHONE NO : 952-230-9886 4801 W. 81ST STREET SE DECISION MADE: 30-JUL-08 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, MN 55437 DEVICE: MODEL 7340 ULTRASOUND SYSTEM ESAOTE, S.P.A. 510(k) NO: K081794(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500 11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 10-JUL-08 CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z6 ETHICON ENDO-SUGERY, LLC 510(k) NO: K080972(TRADITIONAL)
ATTN: RUTH A WOOD PHONE NO : 513-337-3566 4545 CREEK RD. SE DECISION MADE: 03-JUL-08 CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSHEATH LP AND LP-AT FLOWCARDIA, INC. 510(k) NO: K080849(TRADITIONAL)
ATTN: DUSTIN MICHAELS PHONE NO : 408-617-0352 745 N. PASTORIA AVE. SE DECISION MADE: 25-JUL-08 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G FOCUS DIAGNOSTICS, INC. 510(k) NO: K073382(TRADITIONAL)
ATTN: CONSTANCE BRIDGES PHONE NO : 714-503-2007 10703 PROGRESS WAY SE DECISION MADE: 28-JUL-08 CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TLS FIXATION SYSTEM FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K080974(TRADITIONAL)
ATTN: PATRICIA DONNARD PHONE NO : 33 298 556895 ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 01-JUL-08 QUIMPER, FRANCE 29000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO GE HEALTHCARE FINLAND OY 510(k) NO: K081870(SPECIAL)
ATTN: JOHN PENDERGAST PHONE NO : 414-362-2506 8200 WEST TOWER AVENUE SE DECISION MADE: 31-JUL-08 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAC 1600 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K081437(TRADITIONAL)
ATTN: MARGARET MUCHA PHONE NO : 414-721-4535 9900 INNOVATION DR. SE DECISION MADE: 15-JUL-08 RP-2122 510(k) SUMMARY AVAILABLE FROM FDA WAUWATOSA, WI 53226 DEVICE: GE SIGNA MR ONCOLOGY PACKAGE GE MEDICAL SYSTEMS, LLC 510(k) NO: K081916(TRADITIONAL)
ATTN: DANIEL BLANK PHONE NO : 262-521-6467 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 22-JUL-08 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GENADYNE A4 POWERED SUCTION PUMP GENADYNE BIOTECHNOLOGIES, INC. 510(k) NO: K080745(TRADITIONAL)
ATTN: JOHN PAPPAN PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 30-JUL-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME APOLIPOPROTEIN A-1 ASSAY GENERAL ATOMICS 510(k) NO: K072977(TRADITIONAL)
ATTN: ABHIJIT DATTA PHONE NO : 858-455-4762 12889 GREGG COURT SE DECISION MADE: 16-JUL-08 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANNOLIGHT INTENSE PULSED LIGHT SYSTEM GLOBAL USA DISTRIBUTION, LLC. 510(k) NO: K082033(TRADITIONAL)
ATTN: MATT MAKOUSKY PHONE NO : 952-703-5373 10723 AQUILA AV. S. SE DECISION MADE: 31-JUL-08 MINNEAPOLIS, MN 55438 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RELIEVE LAMINOPLASTY FIXATION SYSTEM GLOBUS MEDICAL, INC. 510(k) NO: K080664(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 25-JUL-08 VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA AUDUBON, PA 19403 DEVICE: VIP ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC. 510(k) NO: K081391(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 03-JUL-08 VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA AUDUBON, PA 19403 DEVICE: GN OTOMETRICS INSERT EARPHONES GN OTOMETRICS 510(k) NO: K081234(TRADITIONAL)
ATTN: ERIK GUNDERSEN PHONE NO : 480-241-0085 125 E. COMMERCE DRIVE SE DECISION MADE: 14-JUL-08 SCHAUMBURG, IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZENIEVA GORBEC PHARMACEUTICAL SERVICES, IN510(k) NO: K073246(TRADITIONAL)
ATTN: SANDRA R KIRCUS PHONE NO : 919-281-4080 2445 SOUTH ALSTON AVENUE SE DECISION MADE: 23-JUL-08 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOO GYRUS ACMI, INC. 510(k) NO: K081954(SPECIAL)
ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2600 136 TURNPIKE RD. SE DECISION MADE: 31-JUL-08 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STARCERAM H.C. STARCK CERAMICS GMBH & CO.KG 510(k) NO: K081263(ABBREVIATED)
ATTN: ROBERT N CLARK PHONE NO : 303-463-0900 13605 W. 7TH AVE. SE DECISION MADE: 01-JUL-08 GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AN HARVARD MEDICAL DEVICES LTD. 510(k) NO: K081061(TRADITIONAL)
ATTN: PAUL AYLETT PHONE NO : 852 273 52161 39 CHATHAM ROAD SOUTH SE DECISION MADE: 18-JUL-08 TSIMSHATSUI, KOWLOON, HONG KONG 510(k) STATEMENT DEVICE: TRITANIUM ACETABULAR SHELL SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K081171(TRADITIONAL)
ATTN: KIMBERLY LANE PHONE NO : 201-831-5185 325 CORPORATE DR. SE DECISION MADE: 22-JUL-08 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAX DISTAL FIBULA PLATE HOWMEDICA OSTEONICS CORP. 510(k) NO: K081284(TRADITIONAL)
ATTN: ANDREA M DWYER PHONE NO : 201-831-6250 325 CORPORATE DRIVE SE DECISION MADE: 18-JUL-08 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPERBARIC AMERICA PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER, MO HYPERBARIC AMERICA, LLC 510(k) NO: K081506(ABBREVIATED)
ATTN: TOM WORKMAN PHONE NO : 210-490-6999 18111 COPPER RIDGE DR. SE DECISION MADE: 25-JUL-08 SAN ANTONIO, TX 78259 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDEAL LIFE POD (MODEL ILP 0001) IDEAL LIFE INC. 510(k) NO: K080538(TRADITIONAL)
ATTN: DIANE HORWITZ PHONE NO : 703-242-0027 2995 STEVEN MARTIN DR SE DECISION MADE: 03-JUL-08 FAIRFAX, VA 22031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMO WORKSTATION IMAGE DIAGNOST INTERNATIONAL GMBH 510(k) NO: K081630(ABBREVIATED)
ATTN: PETER HEINLEIN PHONE NO : BALANSTR. 57 SE DECISION MADE: 29-JUL-08 MUENCHEN, GERMANY 81541 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) IMAGE STREAM MEDICAL, INC. 510(k) NO: K081698(ABBREVIATED)
ATTN: CHAS BURR PHONE NO : 781-789-1646 11 MYSTIC AVE. SE DECISION MADE: 30-JUL-08 WINCHESTER, MA 01890-2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCREWINDIRECT DENTAL IMPLANTS IMPLANT DIRECT LLC 510(k) NO: K080633(TRADITIONAL)
ATTN: THOMAS GOTTENBOS PHONE NO : 818-444-3317 27030 MALIBU HILLS RD. SE DECISION MADE: 15-JUL-08 CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-VA VAGINAL LUBRICANT INGFERTILITY, LLC 510(k) NO: K072741(TRADITIONAL)
ATTN: DENNIS CLIFTON PHONE NO : 509-443-0149 17206 S. SPANGLE CREEK RD. SE DECISION MADE: 16-JUL-08 VALLEYFORD, WA 99036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INION SPINAL GRAFT CONTAINMENT SYSTEM INION OY 510(k) NO: K071810(TRADITIONAL)
ATTN: KATI MARTTINEN PHONE NO : 358 108 306600 LAAKARINKATU 2 SE DECISION MADE: 11-JUL-08 TAMPERE, FINLAND 33520 510(k) STATEMENT DEVICE: HEMOSIL D-DIMER INSTRUMENTATION LABORATORY 510(k) NO: K073042(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 31-JUL-08 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM INTERLACE MEDICAL, INC. 510(k) NO: K081070(TRADITIONAL)
ATTN: RON ADAMS PHONE NO : 508-875-1343 139 NEWBURY STREET SE DECISION MADE: 23-JUL-08 FRAMINGHAM, MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER ISCIENCE INTERVENTIONAL 510(k) NO: K080067(TRADITIONAL)
ATTN: GRACE BARTOO PHONE NO : 650-421-2700 4055 CAMPBELL AVENUE SE DECISION MADE: 18-JUL-08 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM ISODOSE CONTROL B.V. 510(k) NO: K081112(ABBREVIATED)
ATTN: HUB VAN DE BERGH PHONE NO : 31 031 8502950 LANDJUWEEL 11 SE DECISION MADE: 29-JUL-08 VEENENDAAL, NETHERLANDS 3905 PE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST IT-V MEDIZINTECHNIK, GMBH 510(k) NO: K081218(TRADITIONAL)
ATTN: CORNELIA DAMSKY PHONE NO : 203-323-7535 56 WESTCOTT ROAD SE DECISION MADE: 21-JUL-08 STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASON ITALIA MEDICA S.R.L. 510(k) NO: K080220(ABBREVIATED)
ATTN: BERTHOIN CLAUDE PHONE NO : 386-672-0450 110 E. GRANADA BLVD. SUITE 207 SE DECISION MADE: 28-JUL-08 ORMOND BEACH, FL 32176 510(k) STATEMENT DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) JIANGSU CUREGUARD GLOVE CO., LTD. 510(k) NO: K081655(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441 ROOM 1606 BLDG. 1 JIANX. YUAN SE DECISION MADE: 21-JUL-08 NO. 209 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA HAIDIAN DISTRICT, BEIJING, CHINA 100083 DEVICE: KEY LASER III 1243 US WITH DETECT KAVO AMERICA 510(k) NO: K073074(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 10-JUL-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FENCER 308 EXCIMER LASER SYSTEM KERA HARVEST/LASER MAX MEDICAL TEC510(k) NO: K080975(TRADITIONAL)
ATTN: PAUL Y FANG PHONE NO : 559-651-2222 1601 NORTH CLANCY STREET SE DECISION MADE: 15-JUL-08 VISALIA, CA 93291-9263 510(k) STATEMENT DEVICE: SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX- KFX MEDICAL 510(k) NO: K081598(SPECIAL)
ATTN: GAYLE HIROTA PHONE NO : 760-444-8844 5845 AVENIDA ENCINAS,SUITE 128 SE DECISION MADE: 03-JUL-08 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM KIMBERLY-CLARK CORP. 510(k) NO: K081089(TRADITIONAL)
ATTN: RICHARD V WOLFE PHONE NO : 770-587-8208 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 14-JUL-08 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES KIMBERLY-CLARK CORP. 510(k) NO: K081260(TRADITIONAL)
ATTN: RICHARD V WOLFE PHONE NO : 770-587-8208 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 09-JUL-08 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED BEAMER SYSTEM C600 KLS MARTIN GMBH + CO. KG 510(k) NO: K081678(ABBREVIATED)
ATTN: BERNHARD HUG PHONE NO : 497 665 9802 AM GANSACKER 1B SE DECISION MADE: 29-JUL-08 UMKIRCH, GERMANY 79224 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SONICWELD RX (RESORB-X) KLS-MARTIN L.P. 510(k) NO: K080862(TRADITIONAL)
ATTN: TOM FAUCETT PHONE NO : 904-641-7746 11239 ST. JOHNS IND PKWY SOUTH SE DECISION MADE: 21-JUL-08 JACKSONVILLE, FL 32246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER IMAGER DRYPRO MODEL 873 KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K081637(SPECIAL)
ATTN: RUSSELL MUNVES PHONE NO : 212-490-4100 140 EAST 45TH ST., 25TH FLOOR SE DECISION MADE: 01-JUL-08 TWO GRAND CENTRAL TOWER 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10017 DEVICE: VALVULOTOME BY KOVEN KOVEN TECHNOLOGY, INC. 510(k) NO: K080178(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 28-JUL-08 HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL SA CEMENT KURARAY MEDICAL INC. 510(k) NO: K081583(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230 600 LEXINGTON AVENUE SE DECISION MADE: 28-JUL-08 26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10022 DEVICE: NUWAV LABORIE MEDICAL TECHNOLOGIES, CORP510(k) NO: K081781(TRADITIONAL)
ATTN: BARBARA MORNET PHONE NO : 802-857-1300 400 AVE D, STE 10 SE DECISION MADE: 09-JUL-08 WILLISTON, VT 05495 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: SKYLINE 55 LARSEN & TOUBRO LIMITED 510(k) NO: K081552(TRADITIONAL) ATTN: A B DESHPANDE PHONE NO : 91 821 240561 KIADB INDUSTRIAL AREA SE DECISION MADE: 31-JUL-08 HEBBAL, HOTTAGALLI 510(k) SUMMARY AVAILABLE FROM FDA MYSORE, KARNATAKA, INDIA 570 018 THIRD PARTY REVIEW DEVICE: NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS LIPOSCIENCE 510(k) NO: K063841(TRADITIONAL)
ATTN: MARK A DEL VECCHIO PHONE NO : 202-637-5600 555 THIRTEENTH STREET NW SE DECISION MADE: 23-JUL-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS LIVE TISSUE CONNECT, INC. 510(k) NO: K071759(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 13TH ST., NW SE DECISION MADE: 30-JUL-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSAIC ECO2 LASER SYSTEM LUTRONIC CORPORATION 510(k) NO: K080496(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 07-JUL-08 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLANT ORTHO ; VISTADENT 3D MATERIALISE DENTAL NV 510(k) NO: K081402(TRADITIONAL)
ATTN: CARL VAN LIERDE PHONE NO : 32 163 96620 TECHNOLOGIELAAN 15 SE DECISION MADE: 18-JUL-08 LEUVEN, BELGIUM 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDELA THOPAZ, MODEL 200 0288 MEDELA AG 510(k) NO: K080212(TRADITIONAL)
ATTN: BRUNO GRETLER PHONE NO : 041 769 5151 LAETTICHSTRASSE 4B SE DECISION MADE: 23-JUL-08 BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDELA INVIA LIBERTY, MODEL 200.1089 MEDELA AG 510(k) NO: K080357(TRADITIONAL)
ATTN: BRUNO GRETLER PHONE NO : 041 769 5151 LAETTICHSTRASSE 4B SE DECISION MADE: 24-JUL-08 BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 MEDI NUCLEAR CORP., INC. 510(k) NO: K080969(TRADITIONAL)
ATTN: JERRY SCHOEN PHONE NO : 800-321-5981 4610 LITTLEJOHN ST. SE DECISION MADE: 25-JUL-08 BALDWIN PARK, CA 91706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER ASPIRATOR, MODEL LS2 OR LS2DP MEDICAL DEVICE RESOURCE CORP. 510(k) NO: K081593(TRADITIONAL)
ATTN: MEL KIMSEY PHONE NO : 510-732-9950 23392 CONNECTICUT ST. SE DECISION MADE: 23-JUL-08 HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELU MEDICAL TECHNOLOGIES OF GEORGIA, I510(k) NO: K080878(TRADITIONAL)
ATTN: CINDI SARTAIN PHONE NO : 770-788-0763 15151 PRATER DRIVE SE DECISION MADE: 17-JUL-08 SUITE E 510(k) SUMMARY AVAILABLE FROM FDA COVINGTON, GA 30014 DEVICE: INSULIN PROTECTOR MEDICOOL, INC. 510(k) NO: K073555(TRADITIONAL)
ATTN: EUGENE CHANG PHONE NO : 310-782-2200 20460 GRAMERCY PL. SE DECISION MADE: 11-JUL-08 TORRANCE, CA 90501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K081676(TRADITIONAL)
ATTN: KYUNG-AM SHIM PHONE NO : 822 219 41381 1003, DAECHI-DONG SE DECISION MADE: 02-JUL-08 GANGNAM-GU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 135-280 THIRD PARTY REVIEW DEVICE: MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET MEDTRADE PRODUCTS LTD. 510(k) NO: K080097(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 011 44 1270500019 ELECTRA HOUSE SE DECISION MADE: 09-JUL-08 CREWE BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA CREWE, CHESHIRE, UNITED KINGDOM CW1 6GL DEVICE: STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE MEDTRONIC NAVIGATION, INC. 510(k) NO: K081512(TRADITIONAL)
ATTN: KEVIN MORNINGSTAR PHONE NO : 720-940-8271 3025 PERRY STREET SE DECISION MADE: 18-JUL-08 DENVER, CO 80212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGENIX PLUS MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K081950(SPECIAL)
ATTN: RYAN MASSEY PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 18-JUL-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERETE 3.0 AND 3.5 MM LOCKING SCREWS MERETE MEDICAL GMBH 510(k) NO: K081513(TRADITIONAL)
ATTN: JORG MIETZNER PHONE NO : 914-967-1532 49 PURCHASE STREET SE DECISION MADE: 18-JUL-08 RYE, NY 10580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFI METRO OPTICS OF AUSTIN, INC. 510(k) NO: K080512(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490 806 KIMBALL AVENUE SE DECISION MADE: 23-JUL-08 GRAND JUNCTION, CO 81501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS MICROVENTION, INC. 510(k) NO: K080666(TRADITIONAL)
ATTN: KEVIN E DALY PHONE NO : 949-461-3314 75 COLUMBIA SE DECISION MADE: 11-JUL-08 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA ALISO VIEJO, CA 92656-1408 DEVICE: LIPO CANNULA MILLENNIUM MEDICAL TECHNOLOGIES, I510(k) NO: K081039(TRADITIONAL)
ATTN: GREGORY M MILES PHONE NO : 909-596-4855 7055 DIVOT DR. SE DECISION MADE: 10-JUL-08 LAVERNE, CA 91750 510(k) STATEMENT DEVICE: SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM MISONIX, INC. 510(k) NO: K070779(TRADITIONAL)
ATTN: RONALD MANNA PHONE NO : 631-694-9555 1938 NEW HIGHWAY SE DECISION MADE: 09-JUL-08 FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM MYLAD ORTHOPEDIC SOLUTIONS, LLC 510(k) NO: K081356(TRADITIONAL)
ATTN: SCOTT EDWARDS PHONE NO : 703-738-6547 8803 WINDY CREEK WAY SE DECISION MADE: 09-JUL-08 MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIOSURG NAKANISHI, INC. 510(k) NO: K073678(TRADITIONAL)
ATTN: KEITH BARRITT PHONE NO : 202-783-5070 1425 K STREET, N.W. SE DECISION MADE: 10-JUL-08 SUITE 1100 510(k) STATEMENT WASHINGTON, DC 20005 DEVICE: KUMAR T-ANCHORS HERNIA SET NASHVILLE SURGICAL INSTRUMENTS 510(k) NO: K081366(TRADITIONAL) ATTN: SARBJEET KUMAR PHONE NO : 615-382-4996 2005 KUMAR LANE SE DECISION MADE: 15-JUL-08 SPRINGFIELD, TN 37172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 NEOMED, INC. 510(k) NO: K081515(SPECIAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678-428-6978 717 LAKEGLEN DR. SE DECISION MADE: 21-JUL-08 SUWANEE, GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILE I.V. SYSTEMS 10,20,60 NORTHWIND TECHNOLOGIES, CORP. 510(k) NO: K080695(ABBREVIATED)
ATTN: DAWN I MOORE PHONE NO : 734-428-8988 20171 BOWENS RD. SE DECISION MADE: 01-JUL-08 MANCHESTER, MI 48158 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUCLEUS-X, MODEL 230X NUMED, INC. 510(k) NO: K081680(SPECIAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491 2880 MAIN ST. SE DECISION MADE: 10-JUL-08 HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD TUBING SETS (STERILE FLUID PATH) NXSTAGE MEDICAL, INC. 510(k) NO: K080807(SPECIAL)
ATTN: MICHAEL DOYLE PHONE NO : 978-687-4700 439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 18-JUL-08 LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT NXSTAGE MEDICAL, INC. 510(k) NO: K081043(TRADITIONAL)
ATTN: MARY LOU STROUMBOS PHONE NO : 978-687-4872 439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 07-JUL-08 LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISENSIA OBS MEDICAL 510(k) NO: K081140(TRADITIONAL)
ATTN: WAYNE NETHERCUTT PHONE NO : 317-819-3937 11495 PENNSYLVANIA ST. STE. SE DECISION MADE: 17-JUL-08 250 510(k) SUMMARY AVAILABLE FROM FDA CARMEL, IN 46032 DEVICE: OSFERION D OLYMPUS TERUMO BIOMATERIALS CORPOR510(k) NO: K081561(TRADITIONAL)
ATTN: STACY A KLUESNER PHONE NO : 484-896-5405 3500 CORPORATE PARKWAY SE DECISION MADE: 28-JUL-08 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM OMEGA CRITICAL CARE LIMITED 510(k) NO: K081776(SPECIAL)
ATTN: ALAN SHORT PHONE NO : 44 135 5265733 OMEGA HOUSE, 2 CAIRN COURT SE DECISION MADE: 22-JUL-08 NERSTON WEST 510(k) SUMMARY AVAILABLE FROM FDA EAST KILBRIDE, UNITED KINGDOM G74 4NB DEVICE: ORTHOPEDIATRICS PEDIPLATES SYSTEM ORTHOPEDIATRICS, CORP. 510(k) NO: K081407(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574-268-6379 210 N. BUFFALO ST. SE DECISION MADE: 22-JUL-08 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT OSMETECH MOLECULAR DIAGNOSTICS 510(k) NO: K073720(TRADITIONAL)
ATTN: ROBERT DICHECK PHONE NO : 626-463-2000 757 SOUTH RAYMOND AVE. SE DECISION MADE: 17-JUL-08 PASADENA, CA 91105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HG II FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K080744(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 267-759-7044 ONE BEN FAIRLESS DR. SE DECISION MADE: 17-JUL-08 FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NT/IT SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K081078(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 267-759-7044 ONE BEN FAIRLESS DR. SE DECISION MADE: 15-JUL-08 FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEXUR M OSTEOTECH, INC. 510(k) NO: K081227(TRADITIONAL)
ATTN: CHRIS TALBOT PHONE NO : 732-542-2800 51 JAMES WAY SE DECISION MADE: 22-JUL-08 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE OSYRIS 510(k) NO: K080731(TRADITIONAL)
ATTN: JAOUAD ZEMMOURI PHONE NO : 330 320 675997 121 RUE CHANZY, BP 90140 SE DECISION MADE: 17-JUL-08 HELLEMMES , FRANCE, FRANCE F59260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOINT STIM, MODEL 1000 PAIN MANAGEMENT TECHNOLOGIES 510(k) NO: K073386(TRADITIONAL)
ATTN: JOSHUA LEFKOVITZ PHONE NO : 800-239-7880 1340 HOME AVE. , BLDG A SE DECISION MADE: 30-JUL-08 AKRON, OH 44310 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOBIOM SPINAL SYSTEM PARADIGM SPINE 510(k) NO: K071668(TRADITIONAL)
ATTN: MARCI HALEVI PHONE NO : 212-583-9700 505 PARK AVE. SE DECISION MADE: 02-JUL-08 14TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10022 DEVICE: PATHWAY PV ATHERECTOMY SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K081328(TRADITIONAL)
ATTN: BRIAN CLEARY PHONE NO : 425-636-4079 10801 120TH AVENUE NE SE DECISION MADE: 17-JUL-08 KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST PATHWORK DIAGNOSTICS, INC. 510(k) NO: K080896(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 408-400-0828 1196 BORREGAS AVE. SE DECISION MADE: 30-JUL-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SUNNYVALE, CA 94089 DEVICE: PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE D PEAK SURGICAL, INC. 510(k) NO: K073057(TRADITIONAL)
ATTN: GRACE CARLSON PHONE NO : 650-331-3020 2464 EMBARCADERO WAY SE DECISION MADE: 22-JUL-08 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K450 POWERED WHEELCHAIR PERMOBIL AB 510(k) NO: K081964(TRADITIONAL)
ATTN: JAN ASTROM PHONE NO : 466 059 5959 BOX 120 SE DECISION MADE: 29-JUL-08 TIMRA, SWEDEN S-861 23 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CX50 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. 510(k) NO: K081802(TRADITIONAL)
ATTN: ROB BUTLER PHONE NO : 978-659-2785 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 11-JUL-08 BOTHELL, WA 98041 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LIFEPAK 20E PHYSIO-CONTROL, INC. 510(k) NO: K073089(TRADITIONAL)
ATTN: MICHELLE ACKERMANN PHONE NO : 425-867-4744 11811 WILLOWS RD., N.E. SE DECISION MADE: 29-JUL-08 PO BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98052 DEVICE: INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VA POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K081826(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-5151 2021 CABOT BLVD. SE DECISION MADE: 25-JUL-08 LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA THERAPY SYSTEM A1000 LASER DEVICE PREMIER DYNAMICS, INC. 510(k) NO: K080689(TRADITIONAL)
ATTN: JOHN J STEPHAN PHONE NO : 248-321-2029 3863 ROCHESTER ROAD SE DECISION MADE: 09-JUL-08 TROY, MI 48083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSTORSOL PRESERVATION SOLUTIONS, INC. 510(k) NO: K073693(TRADITIONAL)
ATTN: NEIL BURRIS PHONE NO : 720-323-1662 4250 GROVE STREET SE DECISION MADE: 03-JUL-08 DENVER, CO 80211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR Q3 INNOVATIONS, LLC 510(k) NO: K080848(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 P.O. BOX 7007 SE DECISION MADE: 25-JUL-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI QUANTUM MEDICAL IMAGING, LLC. 510(k) NO: K080905(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 16-JUL-08 AYER, MA 01432-7661 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEI RADI MEDICAL SYSTEMS AB 510(k) NO: K080813(TRADITIONAL)
ATTN: BJORN PALMGREN PHONE NO : 46 18 161000 PALMBLADSGATAN 10 SE DECISION MADE: 01-JUL-08 UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STATMAP, MODEL 7200 RAMSEY MEDICAL, INC. 510(k) NO: K072109(ABBREVIATED)
ATTN: DARRYL PARMET PHONE NO : 813-289-5555 4920 WEST CYPRESS STREET SE DECISION MADE: 31-JUL-08 TAMPA, FL 33607-3837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE VBS SYSTEM RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K081383(SPECIAL)
ATTN: BRET M BERRY PHONE NO : 801-388-0700 2647 CASSOWARY CIR SE DECISION MADE: 02-JUL-08 SANDY, UT 84092-7116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. 510(k) NO: K080915(TRADITIONAL)
ATTN: HEATHER MACFALLS PHONE NO : 650-605-2257 464 ELLIS ST. SE DECISION MADE: 01-JUL-08 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMIDAIRE 2I RESMED LTD. 510(k) NO: K080797(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 09-JUL-08 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOMELOX RESPIRONICS, INC. 510(k) NO: K081206(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 28-JUL-08 MONROEVILLE, PA 15146 510(k) STATEMENT DEVICE: RAMP NT-PROBNP ASSAY RESPONSE BIOMEDICAL CORP. 510(k) NO: K063662(TRADITIONAL)
ATTN: KEN PILGRIM PHONE NO : 604 456 6010 100 - 8900 GLENLYON PARKWAY SE DECISION MADE: 21-JUL-08 BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS 510(k) NO: K081389(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 317-521-3362 9115 HAGUE ROAD SE DECISION MADE: 15-JUL-08 INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB ROCHE DIAGNOSTICS CORP. 510(k) NO: K080092(TRADITIONAL)
ATTN: STEPHANIE GREEMAN PHONE NO : 317-521-2458 9115 HAGUE RD. BX 50416 SE DECISION MADE: 28-JUL-08 INDIANAPOLIS, IN 46250-0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASHARP CONCENTRIC NEEDLES ROCHESTER ELECTRO MEDICAL, INC. 510(k) NO: K080914(ABBREVIATED)
ATTN: CHARLES C BERKINS PHONE NO : 813-963-2933 4212 CYPRESS GULCH DRIVE SE DECISION MADE: 15-JUL-08 LUTZ, FL 33559 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR SALTER LABS, DIVISION OF REGULATOR510(k) NO: K080922(TRADITIONAL)
ATTN: DUANE KAZAL PHONE NO : 661-854-6818 100 WEST SYCAMORE RD. SE DECISION MADE: 25-JUL-08 ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRACAPS S SDI LTD. 510(k) NO: K081273(TRADITIONAL)
ATTN: RAY CAHILL PHONE NO : 61 3 87277107 5-9 BRUNSDON ST. SE DECISION MADE: 10-JUL-08 BAYSWATER, VICTORIA, AUSTRALIA 315510(k) STATEMENT DEVICE: CAPILLARYS URINE SEBIA 510(k) NO: K080916(SPECIAL)
ATTN: KAREN ANDERSON PHONE NO : 770 446 3707 400-1705 CORPORATE DRIVE SE DECISION MADE: 01-JUL-08 SUITE 400 510(k) STATEMENT NORCROSS, GA 30093 DEVICE: ABL 80 CO-OX SYSTEM SENDX MEDICAL, INC. 510(k) NO: K080370(TRADITIONAL)
ATTN: MARK A DZENDZEL PHONE NO : 760-603-3412 1945 PALOMAR OAKS WAY SE DECISION MADE: 31-JUL-08 CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERIM DISINTEK OPA TEST STRIP SERIM RESEARCH CORP. 510(k) NO: K081370(TRADITIONAL)
ATTN: PATRICIA RUPCHOCK PHONE NO : 574-264-3440 3506 REEDY ST. SE DECISION MADE: 11-JUL-08 ELKHART, IN 46561 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE SHENZHEN EMPEROR ELECTRONIC TECHNO510(k) NO: K081873(TRADITIONAL)
ATTN: CHENG GUIYUAN PHONE NO : 886 755 26073381 TIAN'AN NANYOU INDUSTRIAL AREA SE DECISION MADE: 16-JUL-08 NANSHAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA SHENZHEN, CHINA 518054 THIRD PARTY REVIEW DEVICE: CARDIOSEN'C SHL TELEMEDICINE INTERNATIONAL LTD510(k) NO: K080047(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 11-JUL-08 BINYAMINA, ISRAEL 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYKRES SPINAL SYSTEM SHOWA IKA KOHGYO CO.,LTD. 510(k) NO: K071074(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL, SUITE 20 SE DECISION MADE: 02-JUL-08 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIALO DRAIN SIALO TECHNOLOGY, LTD. 510(k) NO: K072334(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002 20 HATA'AS ST. SE DECISION MADE: 18-JUL-08 KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO IMAGING (VERSION V31) SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K081734(TRADITIONAL)
ATTN: PHONE NO : HENKESTRASSE 127 SE DECISION MADE: 03-JUL-08 ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K081300(SPECIAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891 GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 02-JUL-08 BLDG 500, MS 514, PO BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WI SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K081643(SPECIAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 MS 514, PO BOX 6101 SE DECISION MADE: 03-JUL-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K081683(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 MS 514, PO BOX 6101 SE DECISION MADE: 07-JUL-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081294(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914-524-2443 511 BENEDICT AVE. SE DECISION MADE: 29-JUL-08 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CENTAUR HAVM ASSAY SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081716(SPECIAL)
ATTN: MARY SEEGER PHONE NO : 914-524-2908 511 BENEDICT AVE. SE DECISION MADE: 17-JUL-08 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYMMETRIC TOTAL KNEE SYSTEM SIGNAL MEDICAL CORPORATION 510(k) NO: K080199(TRADITIONAL)
ATTN: BRIAN KATERBERG PHONE NO : 314-775-0518 1000 DES PERES RD. SE DECISION MADE: 03-JUL-08 SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA ST. LOUIS, MO 63131 DEVICE: MONOPOLY PEDICLE SCREW SYSTEM SIGNUS MEDICAL LLC. 510(k) NO: K081108(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 202-552-5800 1331 H ST NW SE DECISION MADE: 14-JUL-08 SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: SINTEA BIOTECH PLS MULTI-AXIAL SCREWS SINTEA BIOTECH, INC. 510(k) NO: K081631(SPECIAL) ATTN: DANIELLE WERNIKOWSKI PHONE NO : 305-673-6226 407 LINCOLN RD. SUITE 10L SE DECISION MADE: 18-JUL-08 MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE SMART GLOVE CORP. SDN BHD 510(k) NO: K081466(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100 LOT 6487 BATU 5 3/4 SE DECISION MADE: 30-JUL-08 JALAN KAPAR 510(k) STATEMENT KLANG SELANGOR, MALAYSIA 42100 DEVICE: ENDOBUTTON CONTINUOUS LOOP (CL) SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K081098(TRADITIONAL)
ATTN: CHRISTINA FLORES PHONE NO : 508-261-3705 150 MINUTEMAN RD. SE DECISION MADE: 16-JUL-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIGALILEO 4TH GENERATION SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K080875(ABBREVIATED)
ATTN: RISHI SINHA PHONE NO : 901-399-6054 1450 BROOKS RD. SE DECISION MADE: 18-JUL-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEGION HINGE KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K081111(TRADITIONAL)
ATTN: NICHOLAS B TABRIZI PHONE NO : 901-399-6017 1450 E BROOKS ROAD SE DECISION MADE: 23-JUL-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDF REVISION HIP SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K081124(ABBREVIATED)
ATTN: RISHI SINHA PHONE NO : 901-399-6054 1450 BROOKS RD. SE DECISION MADE: 31-JUL-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT SMITH & NEPHEW, INC. 510(k) NO: K081351(SPECIAL)
ATTN: NICHOLAS B TABRIZI PHONE NO : 901-399-6017 1450 E BROOKS ROAD SE DECISION MADE: 24-JUL-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WIT SMITHS MEDICAL ASD, INC. 510(k) NO: K081229(TRADITIONAL)
ATTN: BRIAN FARIAS PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 21-JUL-08 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADD MEDICATION CASSETTE RESERVOIR SMITHS MEDICAL MD, INC. 510(k) NO: K081156(TRADITIONAL)
ATTN: DAVID H SHORT PHONE NO : 651-628-7240 1265 GREY FOX RD. SE DECISION MADE: 18-JUL-08 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE SOADCO, S.L. 510(k) NO: K080224(TRADITIONAL)
ATTN: MARIA MITJANETA PHONE NO : 376 800 590 AV FITER I ROSSELL SE DECISION MADE: 03-JUL-08 4 BIS LOCAL 2 510(k) SUMMARY AVAILABLE FROM FDA ESCALDES-ENGORDANY, ANDORRA AD-700 DEVICE: SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESS SOLARIS MEDICAL TECHNOLOGY, INC. 510(k) NO: K073249(TRADITIONAL)
ATTN: ALAN SCHWARTZ PHONE NO : 949-429-5825 55 NORTHERN BLVD. SE DECISION MADE: 25-JUL-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: ENSPLINT TM BONE SCREW SONOMA ORTHOPEDIC PRODUCTS, INC. 510(k) NO: K080778(TRADITIONAL)
ATTN: AMY CONUEL PHONE NO : 707-526-1335 650 LARKFIELD CENTER SE DECISION MADE: 10-JUL-08 SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOPRO 670 ARTHROSCOPIC PUMP SOPRO 510(k) NO: K080122(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 609-828-2428 124 GAITHER DRIVE SE DECISION MADE: 11-JUL-08 SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA MT. LAUREL, NJ 08054 DEVICE: STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K080832(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 30-JUL-08 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPEC SPECTRA MEDICAL DEVICES, INC. 510(k) NO: K081524(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 757-220-8917 4501 GREENDALE DRIVE SE DECISION MADE: 29-JUL-08 WILLIAMSBURG, VA 23188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T-STAT 303 ISCHEMIA MONITORING SYSTEM SPECTROS CORPORATION 510(k) NO: K081233(SPECIAL)
ATTN: BILL CURNAN PHONE NO : 720-348-0389 9433 SOUTH MORNING GLORY LANE SE DECISION MADE: 28-JUL-08 HIGHLANDS RANCH, CO 80130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL ELEMENTS BUTTRESS PLATE SYSTEM SPINAL ELEMENTS, INC. 510(k) NO: K081418(TRADITIONAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 14-JUL-08 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINESMITH CIMPLICITY SPINAL SYSTEM SPINE SMITH PARTNERS L.P. 510(k) NO: K080971(TRADITIONAL)
ATTN: ROBERT JONES PHONE NO : 512-206-0770 8140 N. MOPAC SE DECISION MADE: 02-JUL-08 BLDG II, SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78759 DEVICE: SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM SPINE SMITH PARTNERS L.P. 510(k) NO: K081132(TRADITIONAL)
ATTN: ROBERT JONES PHONE NO : 512-206-0770 8140 N. MOPAC SE DECISION MADE: 14-JUL-08 BLDG II, SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78759 DEVICE: FIXXSURE CROSS LINK SPINEWORKS, LLC 510(k) NO: K081331(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 23-JUL-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPSMEDICAL SPORVIEW PA CULTURE SET SPS MEDICAL SUPPLY CORP. 510(k) NO: K081879(SPECIAL)
ATTN: GARY J SOCOLA PHONE NO : 585-359-0130 6789 WEST HENRIETTA RD. SE DECISION MADE: 30-JUL-08 RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPICOR ABLATION SYSTEM ST. JUDE MEDICAL 510(k) NO: K080292(SPECIAL)
ATTN: KAREN J MCKELVEY PHONE NO : 651-632-9454 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 25-JUL-08 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASU STANBIO LABORATORY 510(k) NO: K081719(SPECIAL)
ATTN: KIRK JOHNSON PHONE NO : 830-249-0772 1261 NORTH MAIN ST. SE DECISION MADE: 18-JUL-08 BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYTO-CHEX BCT STRECK 510(k) NO: K080552(TRADITIONAL)
ATTN: CARL THOMPSON PHONE NO : 402-537-5313 7002 SOUTH 109TH ST. SE DECISION MADE: 31-JUL-08 OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER POWER TOOL NAVIGATOR ATTACHMENT STRYKER CORP. 510(k) NO: K080450(TRADITIONAL)
ATTN: BECKY DITTY PHONE NO : 269-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 17-JUL-08 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER SPINE AVS PL PEEK SPACERS STRYKER CORP. 510(k) NO: K082014(SPECIAL)
ATTN: VIKKI M O'CONNOR PHONE NO : 201-760-8206 2 PEARL COURT SE DECISION MADE: 28-JUL-08 ALLENDALE, NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL MESH -#CM,SIZE X, #,LENGTH GUAGE, INSTRUMENTS, INSTRUME SURGICRAFT LTD. 510(k) NO: K072370(TRADITIONAL)
ATTN: DONALD GUTHNER PHONE NO : 646-460-2984 111 HILL ROAD SE DECISION MADE: 24-JUL-08 DOUGLASSVILLE, PA 19518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535R SURGRX, INC. 510(k) NO: K081129(TRADITIONAL)
ATTN: LINDA OLESON PHONE NO : 650-482-2400 101 SAGINAW DR. SE DECISION MADE: 28-JUL-08 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOMESH SYNTHES (USA) 510(k) NO: K073115(TRADITIONAL)
ATTN: JEFFREY L DOW PHONE NO : 484-356-9720 1230 WILSON DRIVE SE DECISION MADE: 15-JUL-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORIAN DRILLABLE SYNTHES (USA) 510(k) NO: K073303(TRADITIONAL) ATTN: JEFFREY L DOW PHONE NO : 484-356-9720 1230 WILSON DRIVE SE DECISION MADE: 02-JUL-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS SYNTHES (USA) 510(k) NO: K081205(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-719-6941 1301 GOSHEN PKWY SE DECISION MADE: 01-JUL-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES SYNTHES (USA) 510(k) NO: K081353(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-719-6941 1301 GOSHEN PKWY SE DECISION MADE: 23-JUL-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM SYNTHES (USA) 510(k) NO: K081452(TRADITIONAL)
ATTN: JILL R SHERMAN PHONE NO : 610-719-6538 1301 GOSHEN PKWY SE DECISION MADE: 18-JUL-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION SYNTHES (USA) 510(k) NO: K081700(SPECIAL)
ATTN: AMNON TALMOR PHONE NO : 610-719-6604 1301 GOSHEN PKWY. SE DECISION MADE: 17-JUL-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODE TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K081609(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 02-JUL-08 WUGU TOWNSHIP 510(k) STATEMENT TAIPEI COUNTY, CHINA (TAIWAN) 248 DEVICE: FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K081714(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 25-JUL-08 WUGU TOWNSHIP 510(k) STATEMENT TAIPEI COUNTY, CHINA (TAIWAN) 248 DEVICE: VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM, TS600V TALLEY MEDICAL 510(k) NO: K080897(TRADITIONAL)
ATTN: JACK VAN DYKE PHONE NO : 517-290-0089 4740 JADESTONE DR. SE DECISION MADE: 15-JUL-08 WILLIAMSTON, MI 48895 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC. 510(k) NO: K081099(TRADITIONAL)
ATTN: MARY P LEGRAW PHONE NO : 781-357-1709 99 HAYDEN, SUTIE 360 SE DECISION MADE: 15-JUL-08 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICI P AND S SERIES IR CAMERAS TEXAS INFRARED 510(k) NO: K073581(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 512-327-7779 1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 11-JUL-08 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78746 THIRD PARTY REVIEW DEVICE: THD SLIDE THD SPA 510(k) NO: K081429(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LN. SE DECISION MADE: 30-JUL-08 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RSVP PHANTOM PELVIS, MODEL TLP260 THE PHANTOM LABORATORY, INC. 510(k) NO: K081760(TRADITIONAL)
ATTN: JOSHUA LEVY PHONE NO : 518-692-1190 P.O. BOX 511 SE DECISION MADE: 29-JUL-08 SALEM, NY 12865-0511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VU APOD INTERVERTABRAL BODY FUSION DEVICE THEKEN SPINE LLC 510(k) NO: K080822(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330-475-8600 1800 TRIPLETT BLVD. SE DECISION MADE: 02-JUL-08 AKRON, OH 44306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SRT II MUSCLE STIMULATOR THERAPEUTIC INNOVATIONS, INC. 510(k) NO: K071677(TRADITIONAL)
ATTN: HOWARD MANN PHONE NO : 215-369-3785 8903 SPRUCE MILL DRIVE SE DECISION MADE: 11-JUL-08 YARDLEY, PA 19067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS REVERSED SHOULDER PROSTHESIS TORNIER 510(k) NO: K081059(SPECIAL)
ATTN: DAMIEN GUILLAUD PHONE NO : 00 33 476613500 161 RUE LAVOISIER SE DECISION MADE: 17-JUL-08 MONTBONNOT, SAINT-ISMIER, FRANCE 3510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS TORNIER, INC. 510(k) NO: K081707(SPECIAL)
ATTN: JEFF ONDRLA PHONE NO : 574-527-9951 100 CAPITAL DRIVE SE DECISION MADE: 17-JUL-08 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46582 DEVICE: STRESSGARD NIGHTGUARD TOTALGARD CORPORATION 510(k) NO: K072968(TRADITIONAL)
ATTN: LOUIS P IZZI PHONE NO : 781-665-3360 70 WEST FOSTER STREET SE DECISION MADE: 01-JUL-08 MELROSE, MA 02176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 TRAUSON (JIANGSU) MEDICAL INSTRUME510(k) NO: K073159(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467 LANE 999, ZHONGSHAN NO. 2 ROAD SE DECISION MADE: 23-JUL-08 SUITE 8D, NO. 19 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 200030 DEVICE: MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SY TRINITY ORTHOPEDICS, LLC 510(k) NO: K081790(SPECIAL)
ATTN: KEVIN A THOMAS PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 24-JUL-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: COSMIC SYSTEM ULRICH ALBER GMBH & CO. 510(k) NO: K080841(TRADITIONAL)
ATTN: MERLE SYMES PHONE NO : 636-519-0268 754 SPIRIT 40 PARK DR SE DECISION MADE: 23-JUL-08 ST. LOUIS, MO 63005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION FLOW VAPOTHERM, INC. 510(k) NO: K072845(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 17-JUL-08 WASHINGTON, DC 21666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K081188(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY M/S E-110 SE DECISION MADE: 14-JUL-08 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCON ROAMER MICROCATHETER VASCON LLC 510(k) NO: K053310(TRADITIONAL)
ATTN: STEPHEN F VADAS PHONE NO : 305-477-2406 9344 NW 13TH STREET SE DECISION MADE: 03-JUL-08 MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEBRON SSP CERVICAL PLATING SYSTEM VERTEBRON, INC. 510(k) NO: K081567(SPECIAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-9340 80 HATHAWAY DRIVE SE DECISION MADE: 03-JUL-08 STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM VERTEBRON, INC. 510(k) NO: K081597(SPECIAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-9340 400 LONG BEACH BLVD. SE DECISION MADE: 02-JUL-08 STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOCO PROFLUORID VARNISH VOCO GMBH 510(k) NO: K080814(TRADITIONAL)
ATTN: M.TH PLAUMANN PHONE NO : 490 472 17190 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 24-JUL-08 CUXHAVEN, GERMANY D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDODRAPE(TM) VORTEK SURGICAL, LLC 510(k) NO: K080341(ABBREVIATED)
ATTN: THOMAS SZYMCZAK PHONE NO : 317-921-1000 1426 W. 29TH ST. SUITE 300 SE DECISION MADE: 21-JUL-08 INDIANAPOLIS, IN 46208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL HANDPIECES, MIKRO SAW HANDPIECES W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K080939(TRADITIONAL)
ATTN: GABRIELE WIENBECK PHONE NO : 436 274 6236397 53 IGNAZ-GLASER-STRASSE SE DECISION MADE: 29-JUL-08 BUERMOOS, AUSTRIA 5111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE VIABIL BILILARY ENDOPROSTHESIS W.L. GORE & ASSOCIATES INC, MEDICA510(k) NO: K081184(TRADITIONAL)
ATTN: MICHAEL IVEY PHONE NO : 928-864-3790 3250 WEST KILTIE LN. SE DECISION MADE: 22-JUL-08 FLAGSTAFF, AZ 86002-0500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-244 WAKO CHEMICALS USA, INC. 510(k) NO: K080123(TRADITIONAL)
ATTN: PETER PANFILI PHONE NO : 877-714-1924 1600 BELLWOOD ROAD SE DECISION MADE: 17-JUL-08 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-2 WAKO CHEMICALS USA, INC. 510(k) NO: K080125(TRADITIONAL)
ATTN: PETER PANFILI PHONE NO : 877-714-1924 1600 BELLWOOD ROAD SE DECISION MADE: 18-JUL-08 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELL LEAD REINFORCED ENDOTRACHEAL TUBE WELL LEAD MEDICAL INSTRUMENTS 510(k) NO: K073383(TRADITIONAL)
ATTN: ARTHUR J WARD PHONE NO : 813-645-2855 962 ALLERGO LANE SE DECISION MADE: 10-JUL-08 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP WESTMED, INC. 510(k) NO: K081905(TRADITIONAL)
ATTN: CHARLES M HART PHONE NO : 303-358-9302 3957 BLUE PINE CIRCLE SE DECISION MADE: 15-JUL-08 HIGHLANDS RANCH, CO 80126-8077 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ULTRASONIC NEBULISER MODEL 2010 WILFRED KROMKER GMBH 510(k) NO: K072136(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114 S65 W35739 PIPER ROAD SE DECISION MADE: 15-JUL-08 EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLVE EPS SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K081373(TRADITIONAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143 5677 AIRLINE RD. SE DECISION MADE: 03-JUL-08 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES WS FAR IR MEDICAL TECHNOLOGY CO., 510(k) NO: K080465(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488 2904 N BOLDT DRIVE SE DECISION MADE: 18-JUL-08 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO XYLOS SURGICAL MESH XYLOS CORPORATION 510(k) NO: K081882(SPECIAL)
ATTN: GERRY ANN OSTER PHONE NO : 215-867-0220 838 TOWN CENTER DR. SE DECISION MADE: 11-JUL-08 LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 261 TOTAL WITH SUMMARIES 241 TOTAL WITH STATEMENTS 20
Updated August 5, 2008
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