SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-FEB-2009 THROUGH 28-FEB-2009
DEVICE: RADSTAR "FAMILY", MODELS: RADSTAR 4343 & VARIATIONS
5 STAR MEDICAL, INC. 510(k) NO: K083645(TRADITIONAL)
ATTN: TERRY L ANCAR PHONE NO : 727-376-0588
11515 PROSPEROUS DR. SE DECISION MADE: 24-FEB-09
ODESSA, FL 33556 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING
ABBOTT DIABETES CARE INC. 510(k) NO: K083225(TRADITIONAL)
ATTN: SARAH HARRINGTON PHONE NO : 510-239-2732
1360 SOUTH LOOP RD. SE DECISION MADE: 20-FEB-09
ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL-DYN EMERALD SYSTEM
ABBOTT LABORATORIES 510(k) NO: K081495(TRADITIONAL)
ATTN: MICHELLE B ROEDING PHONE NO : 408-567-3781
5440 PATRICK HENRY DR. SE DECISION MADE: 04-FEB-09
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-TORQUE VERSACORE GUIDE WIRE
ABBOTT VASCULAR 510(k) NO: K083706(SPECIAL)
ATTN: NADINE SMITH PHONE NO : 951-914-3311
3200 LAKESIDE DRIVE SE DECISION MADE: 06-FEB-09
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: .035 LOC GUIDE WIRE EXTENSION
ABBOTT VASCULAR 510(k) NO: K083713(SPECIAL)
ATTN: NADINE SMITH PHONE NO : 951-914-3311
3200 LAKESIDE DRIVE SE DECISION MADE: 23-FEB-09
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAD AND TAD II TAPERED GUIDE WIRES
ABBOTT VASCULAR 510(k) NO: K083732(SPECIAL)
ATTN: NADINE SMITH PHONE NO : 951-914-3311
3200 LAKESIDE DRIVE SE DECISION MADE: 25-FEB-09
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
ACRYMED, INC. 510(k) NO: K083103(TRADITIONAL)
ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830
9560 SW NIMBUS AVE SE DECISION MADE: 26-FEB-09
BEAVERTON, OR 97008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-
ACUMEN MEDICAL, INC. 510(k) NO: K083855(SPECIAL)
ATTN: KEVIN MACDONALD PHONE NO : 408-530-1810
275 SANTA ANA COURT SE DECISION MADE: 17-FEB-09
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEONATE HEAD AND BODY COILS
ADVANCED IMAGING RESEARCH, INC. 510(k) NO: K083541(TRADITIONAL)
ATTN: RAVI SRINIVASAN PHONE NO : 216-426-1461
4700 LAKESIDE AVE. SE DECISION MADE: 24-FEB-09
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
CLEVELAND, OH 44114
DEVICE: ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC
ADVANCED MEDICAL INNOVATIONS, INC.510(k) NO: K081398(TRADITIONAL)
ATTN: MARIA F GRIFFIN PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 06-FEB-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: SILVER ALGINATE 11 WOUND DRESSING
ADVANCED MEDICAL SOLUTIONS LIMITED510(k) NO: K090453(SPECIAL)
ATTN: CLAIRE RYAN PHONE NO : 441 616 863500
ROAD THREE SE DECISION MADE: 26-FEB-09
WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD CHESHIRE, UNITED KINGDOM CW7 3PD
DEVICE: ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250
ADVANCED TECHNOLOGY LASER CO., LTD510(k) NO: K083918(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467
LN 999, ZHONGSHAN #2 RD (S) SE DECISION MADE: 02-FEB-09
SUITE 8D, NO. 19 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 20030 THIRD PARTY REVIEW
DEVICE: JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
AGAMATRIX INC 510(k) NO: K083265(SPECIAL)
ATTN: CONNIE HERTEL PHONE NO : 603-328-6051
10 MANOR PARKWAY SE DECISION MADE: 03-FEB-09
SALEM, NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIDERA DIASEND
AIDERA AB 510(k) NO: K083221(TRADITIONAL)
ATTN: ANDERS SONESSON PHONE NO : 46 31 7411785
MEDICINAREGATAN 8A SE DECISION MADE: 03-FEB-09
GOTEBORG, SWEDEN SE 413 46 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRSTRIP OB
AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K090269(TRADITIONAL)
ATTN: WM CAMERON POWELL PHONE NO : 210-805-0444
3303 OAKWELL CT., SUITE 200 SE DECISION MADE: 13-FEB-09
SAN ANTONIO, TX 78218 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: INFINITI VISION SYSTEM WITH OZIL IP
ALCON RESEARCH, LTD. 510(k) NO: K082845(TRADITIONAL)
ATTN: MICHAEL BUENGER PHONE NO : 817-551-6810
6201 SOUTH FREEWAY SE DECISION MADE: 12-FEB-09
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCODR PLUS SYSTEM, MODEL AGM-3000
ALL MEDICUS CO., LTD 510(k) NO: K082328(TRADITIONAL)
ATTN: MARGARET KIM PHONE NO : 82 31 4258288
823 GWANYANG 2-DONG SE DECISION MADE: 27-FEB-09
DONGAN-GU 510(k) SUMMARY AVAILABLE FROM FDA
ANYANG, GYEONGGI-DO, REPUBLIC OF KOREA 431-062
DEVICE: SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS:
ANDON HEALTH CO.,LTD 510(k) NO: K083395(SPECIAL)
ATTN: LIU YI PHONE NO : 86 226 0526161
NO 31, CHANGJIANG ROAD SE DECISION MADE: 27-FEB-09
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: GELPORT SINGLE INCISION ACCESS SYSTEM
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K090275(TRADITIONAL)
ATTN: FRANS VANDEBBROEK PHONE NO : 949-713-8369
22872 AVENIDA EMPRESA SE DECISION MADE: 18-FEB-09
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ASAHI CORSAIR MICROCATHETER
ASAHI INTECC CO., LTD. 510(k) NO: K083127(TRADITIONAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
2500 RED HILL AVE, SUITE 210 SE DECISION MADE: 03-FEB-09
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMABLATE EFFECT
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K081541(TRADITIONAL)
ATTN: ANTJE KATZER PHONE NO : 493 641 7700309
BRUESSELER STR. 10 SE DECISION MADE: 23-FEB-09
JENA, GERMANY 07747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATMOS C361/C451 SUCTION PUMP
ATMOS INC. 510(k) NO: K090445(TRADITIONAL)
ATTN: MARCO SCHLEGEL PHONE NO : 866-862-8667
3717 HUCKLEBERRY ROAD SE DECISION MADE: 27-FEB-09
ALLENTOWN, PA 18104 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AWBAT-S, AWBAT-D, AWBAT-M
AUBREY, INC. 510(k) NO: K082869(TRADITIONAL)
ATTN: STEPHEN MOSS PHONE NO : 760-602-8303
5930 SEA LION PLACE SE DECISION MADE: 06-FEB-09
CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
AUDIFON-USA INC. 510(k) NO: K083488(ABBREVIATED)
ATTN: JANE E PERRONE PHONE NO : 386-338-8812
403 CHAIRMAN CT., STE. 1 SE DECISION MADE: 19-FEB-09
DEBARY, FL 32713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
AVANTIS MEDICAL SYSTEMS, INC. 510(k) NO: K083180(TRADITIONAL)
ATTN: AMRITA SETHI PHONE NO : 408-733-1901
263 SANTA ANA CT. SE DECISION MADE: 12-FEB-09
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILDCAT 7F GUIDEWIRE SUPPORT CATHETER
AVINGER, INC. 510(k) NO: K083313(TRADITIONAL)
ATTN: HIMANSHU PATEL PHONE NO : 650-216-7400
400 CHESAPEAKE DRIVE SE DECISION MADE: 02-FEB-09
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODE
B-K MEDICAL APS 510(k) NO: K083667(TRADITIONAL)
ATTN: LARS OKSBY HANSEN PHONE NO : 011 454 4528100
MILEPARKEN 34 SE DECISION MADE: 02-FEB-09
HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 320
BARRX MEDICAL, INCORPORATED 510(k) NO: K083711(SPECIAL)
ATTN: VIORICA FILIMON PHONE NO : 408-328-7302
540 OAKMEAD PARKWAY SE DECISION MADE: 02-FEB-09
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALO ABLATION CATHETER
BARRX MEDICAL, INCORPORATED 510(k) NO: K083737(SPECIAL)
ATTN: VIORICA FILIMON PHONE NO : 408-328-7302
540 OAKMEAD PARKWAY SE DECISION MADE: 10-FEB-09
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
BAXTER HEALTHCARE CORPORATION 510(k) NO: K083778(SPECIAL)
ATTN: DIANE RENNPFERD PHONE NO : 847-473-6293
1620 WAUKEGAN ROAD SE DECISION MADE: 20-FEB-09
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYST
BECKMAN COULTER, INC. 510(k) NO: K080481(TRADITIONAL)
ATTN: CHECHAMMA VARUGHESE PHONE NO : 952-368-1652
1000 LAKE HAZELTINE DR. SE DECISION MADE: 20-FEB-09
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER BODY FLUID CONTROL
BECKMAN COULTER, INC. 510(k) NO: K082162(TRADITIONAL)
ATTN: LOURDES COBA PHONE NO : 305-380-4079
11800 SW 147TH AVE. SE DECISION MADE: 03-FEB-09
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELMONT HYPERTHERMIA PUMP
BELMONT INSTRUMENT CORP. 510(k) NO: K090089(SPECIAL)
ATTN: URAIWAN LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 12-FEB-09
BILLERICA, MA 01821 510(k) STATEMENT
DEVICE: CHROMOPHARE E 668
BERCHTOLD GMBH & CO. KG 510(k) NO: K090378(TRADITIONAL)
ATTN: HEATH HINES PHONE NO : 800-243-5135
1950 HANAHAN ROAD SE DECISION MADE: 23-FEB-09
CHARLESTON, SC 29406 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE
BEST GLOVE, INC 510(k) NO: K082428(TRADITIONAL)
ATTN: NEIL DOW PHONE NO : 706-862-6712
579 EDISON STREET SE DECISION MADE: 10-FEB-09
MENLO, GA 30731-6335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
BIO-RAD LABORATORIES, INC. 510(k) NO: K080008(TRADITIONAL)
ATTN: CYNTHIA SINCLAIR PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-FEB-09
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOEMG III
BIO-RESEARCH ASSOCIATES, INC. 510(k) NO: K082927(TRADITIONAL)
ATTN: JOHN RADKE PHONE NO : 414-357-7525
9275 NORTH 49TH STREET SE DECISION MADE: 06-FEB-09
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
BROWN DEER, WI 53223
DEVICE: ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -3
BIODEX MEDICAL SYSTEMS, INC. 510(k) NO: K090296(TRADITIONAL)
ATTN: CLYDE SCHLEIN PHONE NO : 631-924-9000
20 RAMSAY RD. SE DECISION MADE: 19-FEB-09
SHIRLEY, NY 11967 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
BIOIMAGENE, INC. 510(k) NO: K080910(TRADITIONAL)
ATTN: INDU LAKSHMAN PHONE NO : 408-207-4242
1601 S. DE ANZA BLVD SE DECISION MADE: 04-FEB-09
SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA
CUPERTINO, CA 95014
DEVICE: WATERLASE MD
BIOLASE TECHNOLOGY, INC. 510(k) NO: K090181(SPECIAL)
ATTN: IOANA RIZOIU PHONE NO : 949-226-8144
4 CROMWELL SE DECISION MADE: 11-FEB-09
IRVINE, CA 92618-1816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO QR ADVANCED FORMULA POWDER
BIOLIFE, LLC 510(k) NO: K080210(TRADITIONAL)
ATTN: KAREN O'TOOLE PHONE NO : 941-360-1300
1235 TALLEVAST RD. SE DECISION MADE: 10-FEB-09
SARASOTA, FL 34243-3271 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
BIOMERIEUX, INC. 510(k) NO: K083383(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 18-FEB-09
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIE
BIOMET MANUFACTURING CORP. 510(k) NO: K083827(SPECIAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 13-FEB-09
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIODRIVE CANNULATED SCREW SYSTEM
BIOMET TRAUMA 510(k) NO: K082874(TRADITIONAL)
ATTN: DEBRA L BING PHONE NO : 973-299-9300
100 INTERPACE PARKWAY SE DECISION MADE: 05-FEB-09
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM
BIOMET, INC. 510(k) NO: K090103(SPECIAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 11-FEB-09
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
BIOPSY SCIENCES, LLC 510(k) NO: K083006(SPECIAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON RD. SE DECISION MADE: 09-FEB-09
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAS ANATOMIX SPINAL SYSTEM
BIOTECHNI AMERICA SPINE GROUP, INC510(k) NO: K083178(TRADITIONAL)
ATTN: DANIEL R BAKER PHONE NO : 206-361-8324
13203 39TH AVE. NE SE DECISION MADE: 23-FEB-09
SEATTLE, WA 98125-4615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GELX ORAL GEL
BMG PHARMA LLC. 510(k) NO: K081372(TRADITIONAL)
ATTN: WILLIAM A GOOLSBEE PHONE NO : 775-265-6529
824 HIGHWAY 88 SE DECISION MADE: 04-FEB-09
GARDNERVILLE, NV 89460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLAZER DX-20 DIAGNOSTIC CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K081576(TRADITIONAL)
ATTN: RONALD C ALLEN PHONE NO : 408-935-6310
150 BAYTECH DRIVE SE DECISION MADE: 03-FEB-09
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPYSCOPE ACCESS AND DELIVERY CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K090170(TRADITIONAL)
ATTN: ASHLEY PYLE PHONE NO : 508-683-4359
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 04-FEB-09
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDONIC M SERIES
BOULE MEDICAL AB 510(k) NO: K083420(SPECIAL)
ATTN: MICHAEL ELLIOTT PHONE NO : 954-791-1773
1800 N.W. 65TH AVE SE DECISION MADE: 03-FEB-09
PLANTATION, FL 33313 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES
BRIDGEPOINT MEDICAL 510(k) NO: K080987(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
8 SNOWBERRY COURT SE DECISION MADE: 06-FEB-09
ORINDA, CA 94563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012
BRIDGEPOINT MEDICAL 510(k) NO: K083727(SPECIAL)
ATTN: JILL MUNSINGER PHONE NO : 763-225-8500
2800 CAMPUS DRIVE #50 SE DECISION MADE: 20-FEB-09
PLYMOUTH, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUSSE SURGICAL DRAPE
BUSSE HOSIPITAL DISPOSABLES 510(k) NO: K083424(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711
75 ARKAY DR SE DECISION MADE: 26-FEB-09
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
C.R. BARD, INC. 510(k) NO: K090101(SPECIAL)
ATTN: JESSICA AGNELLO PHONE NO : 801-522-5651
605 N 5600 W SE DECISION MADE: 10-FEB-09
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSI
C.R. BARD, INC. 510(k) NO: K090102(SPECIAL)
ATTN: JESSICA AGNELLO PHONE NO : 801-522-5000
605 N 5600 W SE DECISION MADE: 12-FEB-09
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLUTIONMD, RELEASE 2.1
CALGARY SCIENTIFIC, INC. 510(k) NO: K082693(TRADITIONAL)
ATTN: PIERRE LEMIRE PHONE NO : 403 270 7159
SUITE 208, 1210 20TH AVENUE SE SE DECISION MADE: 23-FEB-09
CALGARY, ALBERTA, CANADA T2G 1M8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIVA CATALYST III SYSTEM
CARDIVA MEDICAL, INC. 510(k) NO: K082930(TRADITIONAL)
ATTN: KIT CARIQUITAN PHONE NO : 408-400-0856
155 MOFFETT PARK DR., SE DECISION MADE: 13-FEB-09
SUITE A-210 510(k) SUMMARY AVAILABLE FROM FDA
SUNNYVALE, CA 94089
DEVICE: APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
CAYENNE MEDICAL, INC. 510(k) NO: K083607(TRADITIONAL)
ATTN: KERESHMEH SHAHRIARI PHONE NO : 480-502-3661
16597 N. 92ND STREET SE DECISION MADE: 05-FEB-09
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
SCOTTSDALE, AZ 85260
DEVICE: COMPEX SPORT PLUS
CHATTANOOGA GROUP 510(k) NO: K083140(TRADITIONAL)
ATTN: MICHAEL TREAS PHONE NO : 423-870-7207
4717 ADAMS RD. SE DECISION MADE: 09-FEB-09
HIXSON, TN 37343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
CHILDREN'S HEALTH FIRST, INC. 510(k) NO: K081264(TRADITIONAL)
ATTN: ROGER T VAUGHAN PHONE NO : 757-416-8240
5249 SHELLEY PLACE SE DECISION MADE: 13-FEB-09
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOTRACHEAL TUBE
CHILECOM MEDICAL DEVICES CO., LTD.510(k) NO: K080105(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 562-943-4282
155 FLEMINGTON CT. SE DECISION MADE: 13-FEB-09
LA MIRADA, CA 90638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARCORRECT
CLEARCORRECT, INC. 510(k) NO: K082556(TRADITIONAL)
ATTN: WILLIAM GREENROSE PHONE NO : 603-369-3550
220 RIVER ROAD SE DECISION MADE: 06-FEB-09
CLAREMONT, NH 03743 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
COLLAGEN MATRIX, INC. 510(k) NO: K083742(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 12-FEB-09
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPOSIL 2
COLTENE/WHALEDENT AG 510(k) NO: K083304(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 212-289-4748
1349 LEXINGTON AVENUE SE DECISION MADE: 06-FEB-09
NEW YORK, NY 10128 510(k) STATEMENT
DEVICE: POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
COMFORT RUBBER GLOVES IND. SDN. BH510(k) NO: K083624(TRADITIONAL)
ATTN: TAN K BENG PHONE NO : 605 847 2777
LOT 821, JALAN MATANG SE DECISION MADE: 10-FEB-09
34750 MATANG 510(k) STATEMENT
TAIPING, PERAK, MALAYSIA
DEVICE: SCRAMBLER ST 5 TENS DEVICE
COMPETITIVE TECHNOLOGIES,INC. 510(k) NO: K081255(TRADITIONAL)
ATTN: MARY MCNAMARA PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 20-FEB-09
NORTH ATTLEBORO, MA 02760-2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111
CONCENTRIC MEDICAL, INC. 510(k) NO: K090085(SPECIAL)
ATTN: LARAINE PANGELINA PHONE NO : 650-810-1716
301 E. EVELYN AVE. SE DECISION MADE: 12-FEB-09
MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADSTREAM, VERSION 5.0
CONFIRMA, INC. 510(k) NO: K081556(TRADITIONAL)
ATTN: BRENT LEWIS PHONE NO : 425-691-1400
11040 MAIN STREET SE DECISION MADE: 02-FEB-09
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
BELLEVUE, WA 98004
DEVICE: CONTEC POCKET FETAL DOPPLER
CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K082480(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 886 216 4264467
SUITE 8D , ZHONGXIN ZHONGSHAN SE DECISION MADE: 25-FEB-09
MANSION, NO. 19, LANE 999, 510(k) SUMMARY AVAILABLE FROM FDA
ZHONG SHAN, SHANGHAI, CHINA 20030
DEVICE: SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
COOK BIOTECH, INC. 510(k) NO: K082682(TRADITIONAL)
ATTN: DANIEL J DILLON PHONE NO : 765-463-7537
1 GEDDES WAY SE DECISION MADE: 27-FEB-09
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOTIP ULTRA ULTRASOUND NEEDLE
COOK ENDOSCOPY 510(k) NO: K083330(TRADITIONAL)
ATTN: SCOTTIE FARIOLE PHONE NO : 336-744-0157
4900 BETHANIA STATION RD. & SE DECISION MADE: 06-FEB-09
5951 GRASSY CREEK BLVD. 510(k) SUMMARY AVAILABLE FROM FDA
WINSTON-SALEM, NC 27105
DEVICE: CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
COOK, INC. 510(k) NO: K090133(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 20-FEB-09
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEO MAPCATH SENSOR STYLET
CORPAK MEDSYSTEMS 510(k) NO: K083121(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-403-3484
100 CHADDICK DR. SE DECISION MADE: 11-FEB-09
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-
CORPAK MEDSYSTEMS 510(k) NO: K083786(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-403-3484
100 CHADDICK DR. SE DECISION MADE: 20-FEB-09
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
CORVENTIS, INC. 510(k) NO: K083287(ABBREVIATED)
ATTN: DAWN CHANG PHONE NO : 408-790-9322
2226 N. FIRST STREET SE DECISION MADE: 03-FEB-09
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COTTONS 100% NATURAL COTTON TAMPONS
COTTONS PTY, LTD 510(k) NO: K080733(ABBREVIATED)
ATTN: ROBERT SEIPLE PHONE NO : 940-390-0961
3817 SEVILLE RD. SE DECISION MADE: 18-FEB-09
DENTON, TX 76205-8409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPA AMD
COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K082296(TRADITIONAL)
ATTN: JAMES WELSH PHONE NO : 508-261-8532
15 HAMPSHIRE ST. SE DECISION MADE: 26-FEB-09
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOVALVE SG PULMONARY VALVE AND CONDUIT
CRYOLIFE, INC. 510(k) NO: K083106(TRADITIONAL)
ATTN: JOHN D FERROS PHONE NO : 678-290-4525
1655 ROBERTS BLVD., N.W. SE DECISION MADE: 06-FEB-09
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
CULLIGAN SOFT WATER SERVICE CO. 510(k) NO: K082400(TRADITIONAL)
ATTN: MIKE JABLONSKI PHONE NO : 952-912-7381
6030 CULLIGAN WAY SE DECISION MADE: 03-FEB-09
MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPULSE, MODEL: I150
CYDEN LIMITED 510(k) NO: K083748(SPECIAL)
ATTN: MICHAEL KIERNAN PHONE NO : 44 179 2485682
TECHNIUM, KINGS ROAD SE DECISION MADE: 02-FEB-09
THE DOCKS 510(k) STATEMENT
SWANSEA, WALES, UNITED KINGDOM SA1 8PH
DEVICE: DLMS-ZIRBLOCKS
DENTAL MILLING LABORATORY SUPPLIES510(k) NO: K082137(TRADITIONAL)
ATTN: SCOTT ATKIN PHONE NO : 480-948-0466
14201 N. 87TH ST., SUITE A-105 SE DECISION MADE: 10-FEB-09
SCOTTSDALE, AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
DENTALEZ GROUP, STARDENTAL DIVISIO510(k) NO: K083252(TRADITIONAL)
ATTN: DALE BRAAS PHONE NO : 717-291-1161
1816 COLONIAL VILLAGE LN. SE DECISION MADE: 18-FEB-09
LANCASTER, PA 17601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FLUOROCORE 2
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K083326(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-849-4229
221 W. PHILADELPHIA ST. SE DECISION MADE: 10-FEB-09
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: ANATOMIC LOCKING PLATING SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K082300(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-6386
700 ORTHOPAEDIC DR. SE DECISION MADE: 18-FEB-09
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DEPUY NEUFLEX PIP FINGER
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K083107(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 09-FEB-09
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STANDARD WHEELCHAIR PLATFORM
DESIGN SPECIFIC LTD 510(k) NO: K073565(TRADITIONAL)
ATTN: DAWN EDWARDS PHONE NO : 757-587-2082
1310 TEMPLAR BLVD. SE DECISION MADE: 06-FEB-09
NORFOLK, VA 23518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K082462(TRADITIONAL)
ATTN: LIANN VOO PHONE NO : 508-429-0450
333 FISKE ST. SE DECISION MADE: 06-FEB-09
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K083500(TRADITIONAL)
ATTN: THERON GOBER PHONE NO : 770-514-6204
1155 ROBERTS BLVD. SE DECISION MADE: 12-FEB-09
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS AIR-FLOW MASTER
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K082791(TRADITIONAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 919-859-4207
49 PLAIN ST SE DECISION MADE: 18-FEB-09
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMOOTHSHAPES
ELEME MEDICAL, INC. 510(k) NO: K083629(SPECIAL)
ATTN: MICHAIL PANKRATOV PHONE NO : 603-816-1645
HERON COVE OFFICE PARK SE DECISION MADE: 19-FEB-09
10 AL PAUL LANE, SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
MERRIMACK, NH 03054
DEVICE: TENS-EMS-14
EMSI 510(k) NO: K083030(TRADITIONAL)
ATTN: CHERITA JAMES PHONE NO : 703-562-9800
901 KING STREET SE DECISION MADE: 05-FEB-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
ALEXANDRIA, VA 22331 THIRD PARTY REVIEW
DEVICE: FANNING-PAPPAS MODULAR KNEE BEARING
ENDOTEC, INC. 510(k) NO: K081400(TRADITIONAL)
ATTN: MICHAEL PAPPAS PHONE NO : 407-822-0021
2546 HANSROB RD. SE DECISION MADE: 20-FEB-09
ORLANDO, FL 32804 510(k) STATEMENT
DEVICE: ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM
ENERGIST, LTD. 510(k) NO: K082825(TRADITIONAL)
ATTN: TIM MAJOR PHONE NO : 44 179 2798768
2 CLOS LLYN CWM SE DECISION MADE: 06-FEB-09
ENTERPRISE PARK 510(k) STATEMENT
SWANSEA, UNITED KINGDOM SA6 8QY
DEVICE: CARDITTE MICROTEL
ET MEDICAL DEVICES SPA 510(k) NO: K082124(SPECIAL)
ATTN: LUIGI BUCCHI PHONE NO : 39 046 3850125
VIA DE ZINIS 6 SE DECISION MADE: 19-FEB-09
CAVARENO, ITALY 38011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMA-BSM, BETA-BSM
ETEX CORP. 510(k) NO: K090242(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 617-577-7270
38 SIDNEY ST., 3FLR SE DECISION MADE: 20-FEB-09
THE CLARK BLDG. 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139
DEVICE: PORTABLE X-RAY SYSTEM, MODEL DXR -1
EXARO CO., LTD. 510(k) NO: K082875(TRADITIONAL)
ATTN: SHIN KUK YOO PHONE NO : 801-303-7440
215 S. STATE STREET # 100B SE DECISION MADE: 05-FEB-09
SALT LAKE CITY, UT 84111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
FOTONA D.D. 510(k) NO: K083034(TRADITIONAL)
ATTN: STOJAN TROST PHONE NO : 386 1 5009299
STEGNE 7 SE DECISION MADE: 04-FEB-09
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC 800 RESTING ECG ANALYSIS SYSTEM
GE MEDICAL SYST. INFORMATION TECHN510(k) NO: K090212(SPECIAL)
ATTN: LARRY LEPLEY PHONE NO : 414-721-2593
9900 INNOVATION DRIVE SE DECISION MADE: 19-FEB-09
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K083639(TRADITIONAL)
ATTN: LARRY LEPLEY PHONE NO : 414-721-2593
9900 INNOVATION DR. SE DECISION MADE: 17-FEB-09
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
GENESEE BIOMEDICAL, INC. 510(k) NO: K083683(SPECIAL)
ATTN: JOHN T.M. WRIGHT PHONE NO : 303-777-3000
1308 SOUTH JASON ST. SE DECISION MADE: 25-FEB-09
DENVER, CO 80223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160
GENESIS BPS LLC 510(k) NO: K082027(TRADITIONAL)
ATTN: CAROLYN AMDITIS PHONE NO : 201-708-1400
65 COMMERCE WAY SE DECISION MADE: 13-FEB-09
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
GENEXEL-SEIN, INC. 510(k) NO: K080853(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
845 ARONSON LAKE COURT SE DECISION MADE: 20-FEB-09
ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
GISH BIOMEDICAL, INC. 510(k) NO: K080708(TRADITIONAL)
ATTN: HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 02-FEB-09
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
GISH BIOMEDICAL, INC. 510(k) NO: K081947(TRADITIONAL)
ATTN: HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 04-FEB-09
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
GISH BIOMEDICAL, INC. 510(k) NO: K082082(TRADITIONAL)
ATTN: MARTIN SELLERS PHONE NO : 949-635-6200
22942 ARROYO VISTA SE DECISION MADE: 04-FEB-09
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSITION STABILIZATION SYSTEM
GLOBUS MEDICAL INC. 510(k) NO: K073439(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 20-FEB-09
AUDUBON, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORRIDOR FIXATION SYSTEM
GLOBUS MEDICAL, INC. 510(k) NO: K083442(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 06-FEB-09
VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
AUDUBON, PA 19403
DEVICE: GLUSEAL 90, MODEL GLU9010
GLUSTITCH, INC. 510(k) NO: K083752(TRADITIONAL)
ATTN: DON BLACKLOCK PHONE NO : 877 940 2262
#307 7188 PROGRESS WAY SE DECISION MADE: 23-FEB-09
DELTA, B.C., CANADA V4G 1M6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICS CHARTR EP 200
GN OTOMETRICS A/S 510(k) NO: K083399(TRADITIONAL)
ATTN: DAN SANSONETTI PHONE NO : 847-534-6932
125 COMMERCE DRIVE SE DECISION MADE: 20-FEB-09
SCHAUMBURG, IL 60173-5329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOACTYS
GRAFTYS 510(k) NO: K082286(ABBREVIATED)
ATTN: ANTHONY LE NAOUR PHONE NO : 334 426 03000
415 RUE CHARLES NICOLAS LEDOUX SE DECISION MADE: 24-FEB-09
EIFFEL PARK BAT D 510(k) SUMMARY AVAILABLE FROM FDA
AIX EN PROVENCE, FRANCE 13854
DEVICE: GRAFTYS HBS
GRAFTYS 510(k) NO: K082498(ABBREVIATED)
ATTN: ANTHONY LE NAOUR PHONE NO : 33 442 603000
415 RUE CHARLES NICOLAS LEDOUX SE DECISION MADE: 25-FEB-09
EIFFEL PARK BAT D 510(k) SUMMARY AVAILABLE FROM FDA
AIX EN PROVENCE, FRANCE 13854
DEVICE: BIOCRYL X
GREAT LAKES ORTHODONTICS, LTD. 510(k) NO: K083479(TRADITIONAL)
ATTN: MARK LAUREN PHONE NO : 800-828-7626
200 COOPER AVE.DR. SE DECISION MADE: 27-FEB-09
TONAWANDA, NY 14150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TACTIPEN
HASELMEIER GMBH 510(k) NO: K083457(TRADITIONAL)
ATTN: STEPHEN J GOLDNER, JD, RAC PHONE NO : 248-855-5595
30833 NORTHWESTERN HIGHWAY SE DECISION MADE: 13-FEB-09
SUITE 121 510(k) SUMMARY AVAILABLE FROM FDA
FARMINGTON HILL, MI 48334
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED
HEBEI HANDFORM PLASTIC PRODUCTS CO510(k) NO: K082690(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG 1, JIANXIANG SE DECISION MADE: 09-FEB-09
YUAN, NO 209, BEI SI HUAN 510(k) SUMMARY AVAILABLE FROM FDA
ZHONG ROAD; BEIJING, CHINA 100083
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
HEBEI HANDFORM PLASTIC PRODUCTS CO510(k) NO: K082691(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG 1, JIANXIANG SE DECISION MADE: 04-FEB-09
YUAN, NO 209, BEI SI HUAN 510(k) SUMMARY AVAILABLE FROM FDA
ZHONG ROAD; BEIJING, CHINA 100083
DEVICE: ECHELON C MRI SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K083533(TRADITIONAL)
ATTN: DOUG THISTLEHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 17-FEB-09
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 320
HOLLISTER, INC. 510(k) NO: K083153(TRADITIONAL)
ATTN: CHRIS STUKEL PHONE NO : 847-918-3452
2000 HOLLISTER DR. SE DECISION MADE: 04-FEB-09
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
HUBDIC CO., LTD 510(k) NO: K080636(TRADITIONAL)
ATTN: MARIA F GRIFFIN PHONE NO : 631-421-4587
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 13-FEB-09
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMANSCAN CARDIAC ULTRASOUND TRANSDUCER, MODEL ME-3PAC
HUMANSCAN COMPANY, LTD. 510(k) NO: K083824(TRADITIONAL)
ATTN: GARY ALLSEBROOK PHONE NO : 510-388-5001
16303 PANORMIC WAY SE DECISION MADE: 10-FEB-09
SAN LEANDRO, CA 93478-1116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MO
I-SENS, INC. 510(k) NO: K083468(SPECIAL)
ATTN: HYUN JOON OH PHONE NO : 822 916 6191
465-6 WOLGYE-DONG, NOWON-GU SE DECISION MADE: 10-FEB-09
SEOUL, REPUBLIC OF KOREA 139-845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
ICU MEDICAL, INC. 510(k) NO: K082836(SPECIAL)
ATTN: NILOUFAR SAMIMI PHONE NO : 801-264-1410
4455 ATHERTON DRIVE SE DECISION MADE: 25-FEB-09
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FA
INCISIVE SURGICAL, INC. 510(k) NO: K090159(SPECIAL)
ATTN: JAMES PETERSON PHONE NO : 952-591-2543
14405 21ST AVE N. SE DECISION MADE: 06-FEB-09
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE
INION OY 510(k) NO: K090177(SPECIAL)
ATTN: KATI MARTTINEN PHONE NO : 358 108 306600
LAAKARINKATU 2 SE DECISION MADE: 20-FEB-09
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCL
INNOVISION A/S 510(k) NO: K083879(TRADITIONAL)
ATTN: H. CARL JENKINS PHONE NO : 847-234-7500
10 E. SCRANTON AVE. SE DECISION MADE: 23-FEB-09
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
LAKE BLUFF, IL 60044
DEVICE: STRAUMANN DENTAL IMPLANT SYSTEM
INSTITUT STRAUMANN AG 510(k) NO: K081419(TRADITIONAL)
ATTN: LISA QUAGLIA PHONE NO : 978-747-2575
60 MINUTEMAN ROAD SE DECISION MADE: 20-FEB-09
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
INTUITIVE SURGICAL, INC. 510(k) NO: K081137(TRADITIONAL)
ATTN: KAREN UYESUGI PHONE NO : 408-523-8918
1266 KIFER ROAD SE DECISION MADE: 18-FEB-09
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRRISEPT WOUND CLEANSING SYSTEM
IRRIMAX CORPORATION 510(k) NO: K080779(TRADITIONAL)
ATTN: JULIE STEPHENS PHONE NO : 678-513-0693
111 LAUREL RIDGE DRIVE SE DECISION MADE: 04-FEB-09
ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIAC TRIGGER, MODEL: CTM300
IVY BIOMEDICAL SYSTEMS, INC. 510(k) NO: K083854(SPECIAL)
ATTN: DICK LISTRO PHONE NO : 203-481-4183
11 BUSINESS PARK DR. SE DECISION MADE: 13-FEB-09
BRANFORD, CT 06405 510(k) STATEMENT
DEVICE: KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICID
KAREX INDUSTRIES SDN BHD 510(k) NO: K081886(ABBREVIATED)
ATTN: LENG KIAN GOH PHONE NO : 607 688 1996
PTD. 7906/7907, TAMAN PONTIAN SE DECISION MADE: 06-FEB-09
JAYA, BT. 34, JALAN JOHOR 510(k) SUMMARY AVAILABLE FROM FDA
PONTIAN, JOHOR, MALAYSIA 82000
DEVICE: KAT IMPLANT SYSTEM
KAT IMPLANTS, LLC 510(k) NO: K083544(TRADITIONAL)
ATTN: VITALI BONDAR PHONE NO : 603-427-0084
15 RYE STREET SE DECISION MADE: 02-FEB-09
SUITE 115 510(k) SUMMARY AVAILABLE FROM FDA
PORTSMOUTH, NH 03801
DEVICE: KERATEC WOUND DRESSINGS
KERATEC LIMITED 510(k) NO: K080949(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 11-FEB-09
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E.S TECK ( ELECTRO SENSOR TECK)
L.D. TECHNOLOGY, LLC 510(k) NO: K083229(TRADITIONAL)
ATTN: RICHARD CLEMENT PHONE NO : 305-594-2145
11459 NW 34 STREET SE DECISION MADE: 23-FEB-09
MIAMI, FL 33178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LDR SPINE ROI INTERBODY FUSION SYSTEM
LDR SPINE USA 510(k) NO: K082262(TRADITIONAL)
ATTN: NOEL BARTSCH PHONE NO : 512-344-3319
4030 WEST BRAKER LANE SE DECISION MADE: 02-FEB-09
SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78759
DEVICE: LDR SPINE ROI-C IMPLANT
LDR SPINE USA 510(k) NO: K083857(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-344-3319
4030 WEST BRAKER LANE SE DECISION MADE: 12-FEB-09
SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78759
DEVICE: LH-75T PHOTOTHERAPY SYSTEM
LERNER MEDICAL DEVICES, INC. 510(k) NO: K090097(TRADITIONAL)
ATTN: ZAFIRIOS GOURGOULIATOS PHONE NO : 310-914-0091
1545 SAWTELLE BLVD., SUITE 36 SE DECISION MADE: 26-FEB-09
LOS ANGELES, CA 90025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150,
LIFE-TECH, INC. 510(k) NO: K082772(TRADITIONAL)
ATTN: JEFF KASOFF PHONE NO : 281-491-6600
4235 GREENBRIAR DR. SE DECISION MADE: 09-FEB-09
STAFFORD, TX 77477-3995 510(k) STATEMENT
DEVICE: EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION
LINVATEC CORP. 510(k) NO: K083281(TRADITIONAL)
ATTN: LISA ANDERSON PHONE NO : 727-399-5501
11311 CONCEPT BLVD. SE DECISION MADE: 25-FEB-09
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX
MANUFACTURING & RESEARCH, INC. 510(k) NO: K083684(TRADITIONAL)
ATTN: SUZANNE DEW PHONE NO : 520-882-7794
4700 SOUTH OVERLAND DR. SE DECISION MADE: 05-FEB-09
TUCSON, AZ 85745 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH
MAQUET CARDIOPULMONARY AG 510(k) NO: K082117(TRADITIONAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 497 4789210
HECHINGER STRASSE 38 SE DECISION MADE: 18-FEB-09
HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEDOM TOTAL KNEE SYSTEM
MAXX ORTHOPEDICS, INC. 510(k) NO: K082019(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 06-FEB-09
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
MEDEL S.P.A. 510(k) NO: K081463(ABBREVIATED)
ATTN: TERRENCE O'BRIEN PHONE NO : 919-468-9552
112 CAVISTION WAY SE DECISION MADE: 06-FEB-09
CARY, NC 27519 510(k) STATEMENT
DEVICE: EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EA
MEDICA CORP. 510(k) NO: K080874(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892
5 OAK PARK DRIVE SE DECISION MADE: 20-FEB-09
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICID
MEDIVATORS REPROCESSING SYSTEMS 510(k) NO: K082988(TRADITIONAL)
ATTN: LYNN LUEDERS PHONE NO : 763-553-2475
14605 28TH AVE., NORTH SE DECISION MADE: 13-FEB-09
MINNEAPOLIS, MN 55447-4822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDILED PHOTOTHERAPY LAMP
MEDIX I.C.S.A. 510(k) NO: K083179(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 27-FEB-09
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUIBAND TISSUE ADHESIVE, MODEL LB0004
MEDLOGIC GLOBAL LTD. 510(k) NO: K083531(TRADITIONAL)
ATTN: TIERNEY NORSTED PHONE NO : 952-746-8080
5353 WAYZATA BLVD., SUITE 505 SE DECISION MADE: 12-FEB-09
MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
MEDTECHS, LLC 510(k) NO: K083735(TRADITIONAL)
ATTN: MEGHAN ATH PHONE NO : 919-619-7657
111 BEAVER DAM RUN SE DECISION MADE: 18-FEB-09
DURHAN, NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDTOXSCAN
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K080635(TRADITIONAL)
ATTN: PHILLIP HARTZOG PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 13-FEB-09
BURLINGTON, NC 27215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERGRAFT RESORBABLE CERAMIC GRANULES
MEDTRONIC SOFAMOR DANEK 510(k) NO: K082918(TRADITIONAL)
ATTN: RYAN MASSEY PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 09-FEB-09
MEMPHIS, TN 38132-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
MEDTRONIC VASCULAR 510(k) NO: K082873(TRADITIONAL)
ATTN: TARA N TURNEY PHONE NO : 978-739-6654
37A CHERRY HILL DRIVE SE DECISION MADE: 06-FEB-09
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6F TAIGA GUIDING CATHETER
MEDTRONIC VASCULAR 510(k) NO: K083422(SPECIAL)
ATTN: VIC ZHANG PHONE NO : 978-739-308
37A CHERRY HILL DRIVE SE DECISION MADE: 06-FEB-09
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIM 3.0
MEDTRONIC XOMED, INC. 510(k) NO: K083124(TRADITIONAL)
ATTN: JAYME WILSON PHONE NO : 904-296-9600
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 27-FEB-09
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/P
MEMOMETAL TECHNOLOGIES 510(k) NO: K083447(TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 332 990 55969
RUE BLAISE PASCAL SE DECISION MADE: 06-FEB-09
CAMPUS DE KER LANN 510(k) SUMMARY AVAILABLE FROM FDA
BRUZ, FRANCE 35170
DEVICE: NEO-STAT CO2 KG
MERCURY MEDICAL 510(k) NO: K083056(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 23-FEB-09
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K083523(SPECIAL)
ATTN: SUSAN D SCOTT PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 04-FEB-09
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000
METASURG 510(k) NO: K083469(TRADITIONAL)
ATTN: MARK MYERS PHONE NO : 281-398-5656
16350 PARK TEN PL., SUITE 101 SE DECISION MADE: 13-FEB-09
HOUSTON, TX 77084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCERTO DETACHABLE COIL SYSTEM
MICRO THERAPEUTICS, INC. 510(k) NO: K090046(SPECIAL)
ATTN: NEELU MEDHEKAR PHONE NO : 949-680-1209
9775 TOLEDO WAY SE DECISION MADE: 27-FEB-09
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONEVUE
MICROMRI, INC. 510(k) NO: K083691(TRADITIONAL)
ATTN: RICHARD ELRATH PHONE NO : 267-212-1100
580 MIDDLETOWN BLVD. SE DECISION MADE: 25-FEB-09
SUITE D-150 510(k) SUMMARY AVAILABLE FROM FDA
LANGHORNE, PA 19047
DEVICE: MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
MICROSURGEON, INC. 510(k) NO: K082565(TRADITIONAL)
ATTN: DUDLEY HARRIS PHONE NO : 970-252-8107
20363 EAST TULIP CIRCLE SE DECISION MADE: 12-FEB-09
MONTROSE, CO 81403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
MYLAD ORTHOPEDIC SOLUTIONS, LLC 510(k) NO: K090091(SPECIAL)
ATTN: SCOTT EDWARDS PHONE NO : 703-738-6547
8803 WINDY CREEK WAY SE DECISION MADE: 01-FEB-09
MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121,
NCONTACT SURGICAL, INC. 510(k) NO: K090202(SPECIAL)
ATTN: JANE RICUPERO PHONE NO : 919-655-1355
1001 AVIATION PARKWAY SE DECISION MADE: 17-FEB-09
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: NEOSS PROACTIVE IMPLANT
NEOSS, LTD. 510(k) NO: K083561(SPECIAL)
ATTN: CHERITA JAMES PHONE NO : 703-563-9800
901 KING STREET SE DECISION MADE: 11-FEB-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
ALEXANDRIA, VA 22314
DEVICE: NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K090173(TRADITIONAL)
ATTN: TIAN YANFANG PHONE NO : 862 483 660649
NO.3-11, WENHUA ROAD SE DECISION MADE: 05-FEB-09
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW
DEVICE: NOBELACTIVE 8.5 MM & 18.0 MM
NOBEL BIOCARE AB 510(k) NO: K083205(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 13-FEB-09
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
NUBRACE, INC. 510(k) NO: K073121(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST. NW SE DECISION MADE: 12-FEB-09
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
NUTEK ORTHOPAEDICS, INC. 510(k) NO: K082833(TRADITIONAL)
ATTN: PETER MINCIELLI PHONE NO : 954-818-9204
16771 SW 6TH ST. SE DECISION MADE: 05-FEB-09
PEMBROKE PINES, FL 33027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD TUBING SETS (STERILE FLUID PATH)
NXSTAGE MEDICAL, INC. 510(k) NO: K090255(SPECIAL)
ATTN: MICHAEL DOYLE PHONE NO : 978-687-4700
439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 10-FEB-09
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROSCAPE
OLEA MEDICAL 510(k) NO: K083491(TRADITIONAL)
ATTN: NEAL KOLBER PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 19-FEB-09
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD
OMNI LIFE SCIENCE, INC. 510(k) NO: K082468(TRADITIONAL)
ATTN: WILLIAM MCCALLUM PHONE NO : 508-824-2444
175 PARAMOUNT DRIVE SE DECISION MADE: 18-FEB-09
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVICEL APPLICATION DEVICE
OMRIX BIOPHARMACEUTICALS LTD. 510(k) NO: K090162(SPECIAL)
ATTN: SARA HORN PHONE NO : 972 353 16502
MDA BLOOD BANK SE DECISION MADE: 20-FEB-09
SHEBA HOSPITAL, TEL HASHOMER 510(k) STATEMENT
RAMAT GAN, ISRAEL 52621
DEVICE: CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
ORIDION CAPNOGRAPHY, INC. 510(k) NO: K082268(TRADITIONAL)
ATTN: RACHEL WEISSBROD PHONE NO : 972 258 99115
HAR HOTZVIM SCIENCE PARK SE DECISION MADE: 06-FEB-09
POB 45025 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: PERIOGENIX
OROSCIENCE, INC. 510(k) NO: K083516(TRADITIONAL)
ATTN: MARY MCNAMARA PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 20-FEB-09
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K083680(SPECIAL)
ATTN: MARLENE A HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 27-FEB-09
MC 00882 510(k) SUMMARY AVAILABLE FROM FDA
ROCHESTER, NY 14626-5101
DEVICE: MS SYSTEM
OSSTEM IMPLANT CO.,LTD 510(k) NO: K083067(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 888-678-0001
85 BEN FAIRLESS DR. SE DECISION MADE: 02-FEB-09
FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAMEDULLARY FIXATION ROD (IFS)
OSTEOLIGN 510(k) NO: K083458(TRADITIONAL)
ATTN: HOLLACE SAAS RHODES PHONE NO : 202-552-5800
1331 H STREET N.W. SE DECISION MADE: 09-FEB-09
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE IC-PRO SYSTEM, MODEL VERSION 3.2
PAIEON, INC. 510(k) NO: K083745(TRADITIONAL)
ATTN: SHAHAR MANDELBOIM PHONE NO : 972 391 50000
22 HAMELACHA ST., P.O.B. 11355 SE DECISION MADE: 17-FEB-09
ROSH HAAYIN, ISRAEL 48901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR ASPIRE LASER PLATFORM
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K083165(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2300
82 CAMBRIDGE ST. SE DECISION MADE: 13-FEB-09
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERBIUM FRACTIONAL HANDPIECE
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K083900(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2414
82 CAMBRIDGE ST. SE DECISION MADE: 27-FEB-09
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEGRA POSTURE TRAINER
PETER FISCHER 510(k) NO: K081540(TRADITIONAL)
ATTN: PETER FISCHER PHONE NO : 011 49 7071368683
CHRISTOPHSTR. 2 SE DECISION MADE: 20-FEB-09
TUBINGEN, GERMANY D72072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHARMAJET NEEDLE-FREE INJECTION SYSTEM
PHARMAJET, INC. 510(k) NO: K081532(TRADITIONAL)
ATTN: RON BAUER PHONE NO : 303-526-4278
221 CORPORATE CIRCLE SE DECISION MADE: 26-FEB-09
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
GOLDEN, CO 80401
DEVICE: MAMMODIAGNOST VU
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K083740(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 13-FEB-09
Y 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-8431 THIRD PARTY REVIEW
DEVICE: INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, M
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K082583(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : 497 031 4631734
HEWLETT-PACKARD STR.2 SE DECISION MADE: 25-FEB-09
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACP
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K083663(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 25-FEB-09
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUASHIELD SYSTEM
PLASTMED, LTD. 510(k) NO: K083152(TRADITIONAL)
ATTN: ELISSA BURG PHONE NO : 972 4 9873737
BUILDING 7 SE DECISION MADE: 02-FEB-09
P.O.B. 26 510(k) SUMMARY AVAILABLE FROM FDA
TEFEN INDUSTRIAL PARK, ISRAEL 24959
DEVICE: MEDPOR CUSTOMIZED SURGICAL IMPLANT
POREX SURGICAL, INC. 510(k) NO: K083621(TRADITIONAL)
ATTN: JERRI L MANN PHONE NO : 770-515-7735
15 DART RD. SE DECISION MADE: 03-FEB-09
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
PREANALYTIX GMBH 510(k) NO: K082150(SPECIAL)
ATTN: WENDY BALLESTEROS PHONE NO : 201-847-6280
1 BECTON DRIVE SE DECISION MADE: 04-FEB-09
MC 300 510(k) SUMMARY AVAILABLE FROM FDA
FRANKLIN LAKES, NJ 07417
DEVICE: PRODRIVE LINE OF DENTAL HANDPIECES
PRODRIVE SYSTEMS, INC. 510(k) NO: K090369(TRADITIONAL)
ATTN: TIMOTHY F NASON PHONE NO : 866-747-8574
812 COMMERCE DR. SE DECISION MADE: 27-FEB-09
OGDENSBURG, NY 13669 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EYE SPHERES
PRODUCT AND EDUCATIONAL SERVICES L510(k) NO: K082850(TRADITIONAL)
ATTN: EDWARD GRIFFITH PHONE NO : 215-230-7515
3805 OLD EASTON ROAD SE DECISION MADE: 27-FEB-09
DOLYESTOWN, PA 18902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTRON TECHNOLOGIES, LLC "STETHOTRON"
PROTRON TECHNOLOGIES, LLC 510(k) NO: K082771(TRADITIONAL)
ATTN: LEON M DONDYSH PHONE NO : 201-297-7377
141 OAKDENE AVE. SE DECISION MADE: 27-FEB-09
LEONIA, NJ 07605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-00
QUANTRX BIOMEDICAL CORPORATION 510(k) NO: K080436(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858-705-0350
13721 VIA TRES VISTA SE DECISION MADE: 11-FEB-09
SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
QUANTUM CO., LTD. 510(k) NO: K083600(TRADITIONAL)
ATTN: LIJUAN WANG PHONE NO : 86 533 7480087
NO.2-3-18 HUA SHENG YUAN PARK SE DECISION MADE: 19-FEB-09
LINZI 510(k) SUMMARY AVAILABLE FROM FDA
SHANDONG, CHINA 255410
DEVICE: RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
RAD SOURCE TECHNOLOGIES, INC. 510(k) NO: K082921(TRADITIONAL)
ATTN: RANDOL E KIRK PHONE NO : 770-887-8669
6825 SHILOH ROAD EAST SE DECISION MADE: 17-FEB-09
SUITE B2 510(k) SUMMARY AVAILABLE FROM FDA
ALPHARETTA, GA 30005
DEVICE: FLOWTAIN & FLOWTAIN LV
RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K083051(TRADITIONAL)
ATTN: PAULA WENDLAND PHONE NO : 630-773-4009
1540 WEST THORNDALE AVE. SE DECISION MADE: 20-FEB-09
ITASCA, IL 60143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIMIRA IDENTAFI 3000
REMICALM, LLC 510(k) NO: K090135(SPECIAL)
ATTN: DAVID B JONES PHONE NO : 713-984-8550
952 ECHO LANE, SUITE 333 SE DECISION MADE: 17-FEB-09
HOUSTON, TX 77024-2758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
RENU MEDICAL, INC. 510(k) NO: K081927(TRADITIONAL)
ATTN: L. BRUCE PIERSON PHONE NO : 425-353-1110
9800 EVERGREEN WAY SE DECISION MADE: 06-FEB-09
EVERETT, WA 98204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS TOXO IGG CALCHECK
ROCHE DIAGNOSTICS 510(k) NO: K083655(TRADITIONAL)
ATTN: KELLY FRENCH PHONE NO : 317-521-3208
9115 HAGUE ROAD SE DECISION MADE: 12-FEB-09
PO BOX 50416 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-3831
DEVICE: PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGH
SABLE INDUSTRIES, INC. 510(k) NO: K083101(ABBREVIATED)
ATTN: KEVIN RANDALL PHONE NO : 303-828-0844
16576 W. 53RD WAY SE DECISION MADE: 23-FEB-09
GOLDEN, CO 80403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART DILATOR
SAFESTICH MEDICAL, LLC 510(k) NO: K082995(TRADITIONAL)
ATTN: MARIO ARBESU PHONE NO : 305-575-4631
4400 BISCAYNE BLVD. SE DECISION MADE: 06-FEB-09
SUITE 670 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33137
DEVICE: MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K082407(SPECIAL)
ATTN: MARK ROHRER PHONE NO : 205-290-8251
105 CITATION COURT SE DECISION MADE: 03-FEB-09
HOMEWOOD, AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AUTO-BAND LIGATOR
SCANDIMED INTERNATIONAL 510(k) NO: K083556(SPECIAL)
ATTN: STEPHEN M PAGE PHONE NO : 401-862-2236
29 FRIGATE ST. SE DECISION MADE: 19-FEB-09
JAMESTOWN, RI 02835 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
SEASPINE, INC. 510(k) NO: K083338(TRADITIONAL)
ATTN: ETHEL BERNAL PHONE NO : 760-727-8399
2302 LA MIRADA DR. SE DECISION MADE: 02-FEB-09
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
SEDECAL S.A. 510(k) NO: K090238(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
333 MILFORD ROAD SE DECISION MADE: 27-FEB-09
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL PC-860 FETAL DOPPLER
SHENZHEN CREATIVE INDUSTRY CO., LT510(k) NO: K082055(TRADITIONAL)
ATTN: PHONE NO :
2/F, BLOCK 3, NANYOU TIAN'AN SE DECISION MADE: 06-FEB-09
INDUSTRY TOWN 510(k) SUMMARY AVAILABLE FROM FDA
SHENZHEN, GUANGDONG, CHINA 518054 THIRD PARTY REVIEW
DEVICE: DX6605E-TENS, DX6605E-G, DX6609-G
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K082057(TRADITIONAL)
ATTN: PHONE NO :
FANSHENXUSHENG INDUSTRIAL SE DECISION MADE: 26-FEB-09
ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
SHENZHEN, BAO'AN DISTRICT, CHINA 5THIRD PARTY REVIEW
DEVICE: SICAT IMPLANT
SICAT GMBH & CO. KG 510(k) NO: K090119(TRADITIONAL)
ATTN: MARKUS PFISTER PHONE NO : 49 228 85469784
BRUNNENALLEE 6 SE DECISION MADE: 05-FEB-09
BONN, GERMANY D-53177 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083262(TRADITIONAL)
ATTN: LIBBY WARRINER PHONE NO : 916-372-1900
2040 ENTERPRISE BLVD. SE DECISION MADE: 18-FEB-09
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083462(TRADITIONAL)
ATTN: HELEN M LEE PHONE NO : 302-631-8706
500 GBC DRIVE M/S 514 SE DECISION MADE: 27-FEB-09
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMEN
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083465(SPECIAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
SE DECISION MADE: 27-FEB-09
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083579(ABBREVIATED)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
SE DECISION MADE: 20-FEB-09
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K082638(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
PO BOX 6101 SE DECISION MADE: 26-FEB-09
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 FREE T4
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K083373(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914-524-2443
511 BENEDICT AVENUE SE DECISION MADE: 02-FEB-09
TARRYTOWN, NY 10509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESCISION OPTION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K082775(TRADITIONAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925-602-8157
4040 NELSON AVE. SE DECISION MADE: 19-FEB-09
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K090276(TRADITIONAL)
ATTN: SHELLY PEARCE PHONE NO :
1230 SHOREBIRD WAY SE DECISION MADE: 19-FEB-09
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K090334(TRADITIONAL)
ATTN: SHELLY PEARCE PHONE NO : 650-694-5988
1230 SHOREBIRD WAY SE DECISION MADE: 20-FEB-09
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
SMITH & NEPHEW, INC. 510(k) NO: K082371(TRADITIONAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520
1450 BROOKS RD. SE DECISION MADE: 09-FEB-09
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
SMITH & NEPHEW, INC. 510(k) NO: K083375(TRADITIONAL)
ATTN: LAURA KREJCI PHONE NO : 727-329-7702
970 LAKE CARILLON DR. SE DECISION MADE: 25-FEB-09
SUITE 110 510(k) SUMMARY AVAILABLE FROM FDA
ST. PETERSBURG, FL 33716
DEVICE: PIGALILEO V3.0 HIP
SMITH & NEPHEW, INC. 510(k) NO: K083565(SPECIAL)
ATTN: GINO ROUSS PHONE NO : 901-399-6707
1450 BROOKS RD. SE DECISION MADE: 20-FEB-09
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIVONA TRACHEOSTOMY TUBES
SMITHS MEDICAL ASD, INC. 510(k) NO: K083641(TRADITIONAL)
ATTN: DANIEL COATES PHONE NO : 219-989-9150
5700 WEST 23RD AVE. SE DECISION MADE: 23-FEB-09
GARY, IN 46406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVAC AUTO RETRACTABLE SAFETY SYRINGE
SON MEDICAL 510(k) NO: K083193(TRADITIONAL)
ATTN: RICHARD THERIAULT PHONE NO : 617-438-4315
2073 SHELL RING CIRCLE SE DECISION MADE: 13-FEB-09
MOUNT PLEASANT, SC 29466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGER DISCECTOMY DEVICE
SPINAL DEVICES, LLC 510(k) NO: K081240(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999
13540 GUILD AVE SE DECISION MADE: 27-FEB-09
APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXXION LIGHT GUIDE
SPINAL ELEMENTS, INC. 510(k) NO: K082992(TRADITIONAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 18-FEB-09
CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUCENT MAGNUM
SPINAL ELEMENTS, INC. 510(k) NO: K083475(TRADITIONAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-0121
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 13-FEB-09
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE
SPINEART 510(k) NO: K081888(TRADITIONAL)
ATTN: FRANCK PENNESI PHONE NO : 41 227 994025
COINTRIN 20 ROUTE DE PRE-BOIS SE DECISION MADE: 06-FEB-09
CP1813 510(k) SUMMARY AVAILABLE FROM FDA
GENEVA, SWITZERLAND 1215
DEVICE: MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
STRAUMANN MANUFACTURING, INC. 510(k) NO: K090260(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN RD. SE DECISION MADE: 26-FEB-09
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN DENTAL IMPLANT SYSTEM
STRAUMANN USA 510(k) NO: K083550(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 978-747-2513
60 MINUTEMAN ROAD SE DECISION MADE: 26-FEB-09
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-CAL
STRECK 510(k) NO: K083200(TRADITIONAL)
ATTN: ERIN JOHNSON PHONE NO : 402-537-5311
7002 SOUTH 109TH ST. SE DECISION MADE: 03-FEB-09
OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD4 COUNT
STRECK 510(k) NO: K083926(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 402-537-5215
7002 SOUTH 109TH ST. SE DECISION MADE: 11-FEB-09
OMAHA, NE 68128 510(k) STATEMENT
DEVICE: AVS TL PEEK SPACERS
STRYKER CORP. 510(k) NO: K083661(TRADITIONAL)
ATTN: KIMBERLY LANE PHONE NO : 201-760-8215
2 PEARL COURT SE DECISION MADE: 27-FEB-09
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 600
STRYKER LEIBINGER GMBH & CO. KG 510(k) NO: K083009(TRADITIONAL)
ATTN: LILIAN ECKERT PHONE NO : 497 614 512117
BOTZINGER STRASSE 41 SE DECISION MADE: 19-FEB-09
FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SUQIAN CLEAN GLOVE CO., LTD. 510(k) NO: K090016(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441
RM.1606 BLDG.1, JIANXIANG YUAN SE DECISION MADE: 13-FEB-09
NO.209, BEISI HUAN ZHONG RD. 510(k) STATEMENT
HAI DIAN DISTRICT, BEIJING, CHINA 100083
DEVICE: EEA HEMORRHOID STAPLER & ACCESSORIES
SURGICAL DEVICES, A GLOBAL BUSINES510(k) NO: K083781(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-492-5352
60 MIDDLETOWN AVE SE DECISION MADE: 04-FEB-09
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
SYNTHES (USA) 510(k) NO: K083439(TRADITIONAL)
ATTN: AMNON TALMOR PHONE NO : 610-719-6604
1301 GOSHEN PKWY. SE DECISION MADE: 05-FEB-09
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
SYSMEX AMERICA, INC. 510(k) NO: K083002(SPECIAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 03-FEB-09
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA IR22 EAR THERMOMETER, MODEL TD-1262
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K090294(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 2 66258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 26-FEB-09
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE
TANGSHAN ZHONGYING PLASTIC PRODUCT510(k) NO: K083259(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909-548-4828
12390 EAST END AVE. SE DECISION MADE: 17-FEB-09
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIMEND
TEI BIOSCIENCES INC. 510(k) NO: K083898(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS ST. SE DECISION MADE: 04-FEB-09
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIX IMAGING
TELEVERE SYSTEMS 510(k) NO: K082623(TRADITIONAL)
ATTN: BARBARA DEAY PHONE NO : 800-385-9593
471 STAGE RD. SE DECISION MADE: 25-FEB-09
CHARLTON, NY 12019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENSCARE ITOUCH MODEL(S) EASY AND PLUS
TENSCARE LTD 510(k) NO: K082377(ABBREVIATED)
ATTN: ANTHONY JANKEL PHONE NO : 011 441 372723434
9 BLENHEIM ROAD SE DECISION MADE: 09-FEB-09
EPSOM, UNITED KINGDOM KT19 9BE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K082321(TRADITIONAL)
ATTN: GARY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 13-FEB-09
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
TERUMO MEDICAL CORP. 510(k) NO: K090040(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
950 ELKTON BLVD. SE DECISION MADE: 06-FEB-09
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
THE BINDING SITE, LTD. 510(k) NO: K082129(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 10-FEB-09
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: CROSSOVER
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K083269(TRADITIONAL)
ATTN: TIM STOUDT PHONE NO : 610-296-3000
65 GREAT VALLEY PKWY. SE DECISION MADE: 03-FEB-09
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETRACTOR LITE
THOMAS SURGICAL INSTRUMENTS, INC. 510(k) NO: K083710(TRADITIONAL)
ATTN: STEPHANIE A ZALUCHA PHONE NO : 231-922-5170
10170 E. CHERRY BEND RD. SE DECISION MADE: 23-FEB-09
TRAVERSE CITY, MI 49684 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER, INC., INSITE SUTURE ANCHORS
TORNIER, INC. 510(k) NO: K083268(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
100 CUMMINGS CENTER SE DECISION MADE: 12-FEB-09
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: DRAD30003/RADREX-I
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K083503(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 13-FEB-09
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: APLIO ARTIDA V2.0 SSH-880CV
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K090158(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR SE DECISION MADE: 06-FEB-09
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COLON VIEW, MODEL CSCV-001A
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K090220(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DRIVE SE DECISION MADE: 11-FEB-09
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781 THIRD PARTY REVIEW
DEVICE: SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM A
TRANSOMA 510(k) NO: K083828(SPECIAL)
ATTN: LISA STONE PHONE NO : 651-414-5521
119 14TH STREET NW SE DECISION MADE: 11-FEB-09
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQ-PRC LC WARFARIN GENOTYPING KIT, AND TRIMGEN BUCCALQUICK WITH
TRIMGEN CORPORATION 510(k) NO: K073071(TRADITIONAL)
ATTN: HOWARD DOONG PHONE NO : 410-472-1100
34 LOVETON CIRCLE, SUITE 210 SE DECISION MADE: 06-FEB-09
SPARKS, MD 21152-9202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUOVOGUARD
U.S. SAFETY SYRINGES CO., INC. 510(k) NO: K090122(TRADITIONAL)
ATTN: CHRISTINA SMITH PHONE NO : 888-645-2795
1676 VILLAGE GREEN SE DECISION MADE: 05-FEB-09
CROFTON, MD 21114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024
US DIAGNOSTICS, INC. 510(k) NO: K082201(TRADITIONAL)
ATTN: JONATHAN J JOHNSON PHONE NO : 212-674-3636
304 PARK AVENUE SOUTH SE DECISION MADE: 20-FEB-09
SUITE 218 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10010-4301
DEVICE: VASCUTEK CANNULA GRAFT, MODEL CGS2008S
VASCUTEK LTD. 510(k) NO: K081560(TRADITIONAL)
ATTN: KAREN KELSO PHONE NO : 141 812 5555
NEWMAINS AVE. SE DECISION MADE: 10-FEB-09
INCHINNAN INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
RENFREWSHIRE, SCOTLAND, UNITED KINGDOM PA4 9RR
DEVICE: FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
VITROLIFE SWEDEN AB 510(k) NO: K082727(TRADITIONAL)
ATTN: KJELL KJORK PHONE NO : 463 172 18077
FAKTORVAGEN 13 SE DECISION MADE: 06-FEB-09
KUNGSBACKA, SWEDEN SE-434 37 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIFIX SE
VOCO GMBH 510(k) NO: K083438(TRADITIONAL)
ATTN: TH. PLAUMANN PHONE NO : 49 472 1719200
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 13-FEB-09
CUXHAVEN, GERMANY D-27472 510(k) STATEMENT
DEVICE: IMAG, IPOD, EZ-FIND AND ISLIDE
VOGUESTRAP 510(k) NO: K090362(TRADITIONAL)
ATTN: MARIA F GRIFFIN PHONE NO : 704-843-1675
55 NORTHERN BLVD SE DECISION MADE: 27-FEB-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021 THIRD PARTY REVIEW
DEVICE: GORE NEURO PROTECTION SYSTEM
W.L. GORE & ASSOCIATES,INC 510(k) NO: K083300(TRADITIONAL)
ATTN: MICHELLE A WELLS PHONE NO : 800-437-8181
4250 W. KILTIE LANE SE DECISION MADE: 04-FEB-09
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATION PROBES
WE SENSE LTD 510(k) NO: K082404(TRADITIONAL)
ATTN: NABIL JADAON PHONE NO : 972 465 64222
2 EKSAL ST SE DECISION MADE: 25-FEB-09
PO BOX 50736 510(k) SUMMARY AVAILABLE FROM FDA
NAZARETH, ISRAEL 16000
DEVICE: ADVANCE A-CLASS TIBIAL INSERT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K081479(TRADITIONAL)
ATTN: FRED W BOWMAN PHONE NO : 901-867-4497
5677 AIRLINE RD. SE DECISION MADE: 20-FEB-09
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXXENT SURFACE APPLICATOR, MODEL 710257
XOFT, INC. 510(k) NO: K083734(TRADITIONAL)
ATTN: STEVE LIN PHONE NO : 408-419-2300
345 POTRERO AVE. SE DECISION MADE: 11-FEB-09
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
ZARGIS MEDICAL CORP. 510(k) NO: K083309(SPECIAL)
ATTN: JOHN KALLASSY PHONE NO : 609-734-4747
2 RESEARCH WAY, 1ST FLOOR SE DECISION MADE: 13-FEB-09
PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-10
ZEN STRONG MEDICAL TECHNOLOGY CO.,510(k) NO: K090027(SPECIAL)
ATTN: CHENG ROIE-SHENG PHONE NO : 886 224 570547
6F,NO.88 NING JIN ST. SE DECISION MADE: 02-FEB-09
NUANNUAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
KEELUNG CITY, CHINA (TAIWAN) 20542
DEVICE: LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
ZEST ANCHORS, INC. 510(k) NO: K083324(SPECIAL)
ATTN: RICHARD A OVERTON PHONE NO : 760-743-7744
2061 WINERIDGE PL. SE DECISION MADE: 25-FEB-09
ESCONDIDO, CA 92029 510(k) STATEMENT
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ZIBO WANCI PLASTIC & RUBBER CO., L510(k) NO: K083047(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909-548-4828
12390 EAST END AVE. SE DECISION MADE: 12-FEB-09
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANT
ZIMMER, INC. 510(k) NO: K083497(TRADITIONAL)
ATTN: CAROL VIERLING PHONE NO : 574-372-4964
345 E. MAIN ST. SE DECISION MADE: 19-FEB-09
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS
ZIMMER, INC. 510(k) NO: K083654(SPECIAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574-372-4570
P.O. BOX 708 SE DECISION MADE: 26-FEB-09
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 265
TOTAL WITH SUMMARIES 244
TOTAL WITH STATEMENTS 21
Updated March 5, 2009
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