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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