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Medical Devices
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March 2009 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-MAR-2009 THROUGH 31-MAR-2009
DEVICE: HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 0
ABBOTT VASCULAR 510(k) NO: K083738(SPECIAL)
ATTN: NADINE SMITH PHONE NO : 951-914-3311
3200 LAKESIDE DRIVE SE DECISION MADE: 11-MAR-09
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20,
ABBOTT VASCULAR-VASCULAR SOLUTIONS510(k) NO: K090509(SPECIAL)
ATTN: NADINE SMITH PHONE NO : 951-914-3311
3200 LAKESIDE DR. SE DECISION MADE: 20-MAR-09
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE WAND MICROACCESS SAFETY INTRODUCER
ACCESS SCIENTIFIC, INC. 510(k) NO: K090372(TRADITIONAL)
ATTN: ALBERT MISAJON PHONE NO : 858-259-8333
12526 HIGH BLUFF DRIVE SE DECISION MADE: 30-MAR-09
SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES
ACCUTECH MEDICAL TECHNOLOGIES, INC510(k) NO: K090281(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200
3637 BERNAL AVE SE DECISION MADE: 04-MAR-09
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE
ADAPTIVE SPECIALTY, LLC 510(k) NO: K083425(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-590-5810
1001 OAKWOOD BLVD SE DECISION MADE: 20-MAR-09
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS PROXIMAL HUMERAL NAIL
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K090478(SPECIAL)
ATTN: PAUL DONER PHONE NO : 310-533-9966
386 BEECH AVENUE SE DECISION MADE: 26-MAR-09
UNIT B6 510(k) SUMMARY AVAILABLE FROM FDA
TORRANCE, CA 90501
DEVICE: PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE
ADVANCED VASCULAR DYNAMICS 510(k) NO: K090286(TRADITIONAL)
ATTN: HERBERT J SEMLER PHONE NO : 503-223-2333
1910 NW 23RD PLACE SE DECISION MADE: 23-MAR-09
PORTLAND, OR 97210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EK/P. AERUGINOSA PNA FISH
ADVANDX, INC. 510(k) NO: K081433(TRADITIONAL)
ATTN: HENRIK STENDER PHONE NO : 781-376-0009
10A ROESSLER ROAD SE DECISION MADE: 26-MAR-09
WOBURN, MA 01801 510(k) STATEMENT
DEVICE: AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K083311(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072
3773 CORPORATE PWKY. SE DECISION MADE: 04-MAR-09
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERO DV TRACHEOBRONCHIAL STENT SYSTEM
ALVEOLUS, INC 510(k) NO: K083625(TRADITIONAL)
ATTN: TONY ALEXANDER PHONE NO : 704-926-4837
9013 PERIMETER WOODS DR. SE DECISION MADE: 11-MAR-09
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CHARLOTTE, NC 28216
DEVICE: PICASSO LASER SYSTEM
AMD LASERS, LLC 510(k) NO: K083142(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 13-MAR-09
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNUM M FIXATION DEVICE
ARTHROCARE CORP. 510(k) NO: K090380(SPECIAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-585-2406
680 VAQUEROS AVE. SE DECISION MADE: 13-MAR-09
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRICURE CRYO1 CRYO-ABLATION PROBE
ATRICURE, INC. 510(k) NO: K082074(TRADITIONAL)
ATTN: JAMES LUCKY PHONE NO : 513-755-5754
6033 SCHUMACHER PARK DR. SE DECISION MADE: 02-MAR-09
WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PI
AUDIO TECHNOLOGIES S.R.L. 510(k) NO: K083780(TRADITIONAL)
ATTN: FRANCO BEONI PHONE NO : 390 523 778864
VIA VALLERA, 42 SE DECISION MADE: 23-MAR-09
PIACENZA, ITALY I-29100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOND BONE
AUGMA BIOMATERIALS, LTD. 510(k) NO: K083858(TRADITIONAL)
ATTN: DAVID J COLLETTE PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 17-MAR-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: PRONTOSAN ANTIMICROBIAL WOUND GEL
B. BRAUN MEDICAL, INC. 510(k) NO: K090141(TRADITIONAL)
ATTN: LISA GIAQUINTO PHONE NO : 610-596-2354
901 MARCON BLVD. SE DECISION MADE: 17-MAR-09
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-50 SERIES SPO2 SENSOR
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K082487(TRADITIONAL)
ATTN: LEI CHEN PHONE NO : 86 10 88790480
ROOM 1127-1128 BUILDING B SE DECISION MADE: 04-MAR-09
BAILANGYUAN FUXING RD. #A36 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100039
DEVICE: I_OPEN 0.4T
BEIJING WANDONG MEDICAL EQUIPMENT 510(k) NO: K090433(TRADITIONAL)
ATTN: PHONE NO :
NO. 7, SANJIANFANG NANLI SE DECISION MADE: 25-MAR-09
CHAO YANG DISTRICT, BEIJING, CHINA510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: THE BELMONT BUDDY LITE FLUID WARMER
BELMONT INSTRUMENT CORP. 510(k) NO: K090508(SPECIAL)
ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 26-MAR-09
BILLERICA, MA 01821 510(k) STATEMENT
DEVICE: OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
BIEN-AIR SURGERY SA 510(k) NO: K083720(TRADITIONAL)
ATTN: HUGUES FROIDEVAUX PHONE NO : 41 329 533535
RUE DE L'OUEST 2B SE DECISION MADE: 20-MAR-09
LE NOIRMONT, SWITZERLAND 2340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MO
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K082190(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 917 74300
BMR HOUSE SE DECISION MADE: 11-MAR-09
PARKMORE BUSINESS PARK, WEST 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: ACTICARE IC AND TSE
BIOINDUCTION LIMITED 510(k) NO: K081835(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167
2300 MCDERMOTT ROAD SE DECISION MADE: 19-MAR-09
SUITE 200-207 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75025
DEVICE: VITEK 2 GRAM NEGATIVE DORIPENEM
BIOMERIEUX, INC. 510(k) NO: K082346(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 16-MAR-09
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY ELBOW - X-SMALL
BIOMET MANUFACTURING CORP. 510(k) NO: K090473(SPECIAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 25-MAR-09
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
BIOPRO, INC. 510(k) NO: K083490(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 18-MAR-09
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005
BIOPSY SCIENCES, LLC 510(k) NO: K090501(SPECIAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON RD. SE DECISION MADE: 05-MAR-09
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-12
BIOSENSE WEBSTER, INC. 510(k) NO: K090120(SPECIAL)
ATTN: BALAKA DAS PHONE NO : 909-839-8599
3333 DIAMOND CANYON RD. SE DECISION MADE: 24-MAR-09
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYGEN DEMAND VALVE
BPR MEDICAL, LTD. 510(k) NO: K082345(TRADITIONAL)
ATTN: BEN JOHNSON PHONE NO : 44 162 3628281
22, HAMILTON WAY SE DECISION MADE: 13-MAR-09
MANSFIELD, NOTTINGHAMSHIRE, UNITED510(k) STATEMENTU
DEVICE: BRIT PACS SYSTEMS
BRIT SYSTEMS, INC. 510(k) NO: K081168(TRADITIONAL)
ATTN: ROBERT MURRY PHONE NO : 214-630-0636
1909 HI-LINE DR., SE DECISION MADE: 23-MAR-09
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75207
DEVICE: LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
BRONCUS TECHNOLOGIES, INC. 510(k) NO: K090095(TRADITIONAL)
ATTN: MAHTAB FATEMI PHONE NO : 650-428-1600
1400 NORTH SHORELINE BLVD., SE DECISION MADE: 13-MAR-09
SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94043-1346 THIRD PARTY REVIEW
DEVICE: BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S)
BTLOCK SRL 510(k) NO: K083869(ABBREVIATED)
ATTN: ESTHER BATTILANA PHONE NO : 390 444 492609
VIA MADONNETTA 97/C SE DECISION MADE: 27-MAR-09
MONTECCHIO MAGGIORE, VICENZA, ITAL510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL, MODEL SP-001
C-RAD POSITIONING AB 510(k) NO: K082582(TRADITIONAL)
ATTN: CRISTINA SVENSSON PHONE NO : 461 866 6930
BREDGRAND 14 SE DECISION MADE: 30-MAR-09
UPPSALA, SWEDEN 75320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
C.R. BARD, INC. 510(k) NO: K083675(TRADITIONAL)
ATTN: JESSICA AGNELLO PHONE NO : 801-595-0700
605 NORTH 5600 WEST SE DECISION MADE: 19-MAR-09
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRO
C.R. BARD, INC. 510(k) NO: K090512(SPECIAL)
ATTN: ANGELA M BRADY PHONE NO : 801-522-5000
605 NORTH 5600 WEST SE DECISION MADE: 27-MAR-09
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
C.R. BARD, INC. 510(k) NO: K090547(SPECIAL)
ATTN: CINDY MOSS PHONE NO : 480-379-2836
1625 WEST 3RD ST. SE DECISION MADE: 18-MAR-09
TEMPE, AZ 85281-2438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG
CADI SCIENTIFIC PTE.LTD 510(k) NO: K083185(TRADITIONAL)
ATTN: STEPHEN H GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER ROAD SE DECISION MADE: 11-MAR-09
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCEND
CALDERA MEDICAL, INC. 510(k) NO: K083722(TRADITIONAL)
ATTN: MARA KORSUNSKY PHONE NO : 818-879-6555
28632 ROADSIDE DR., SUITE 260 SE DECISION MADE: 31-MAR-09
AGOURA HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY CXDI-40G COMPACT
CANON U.S.A., INC. 510(k) NO: K090623(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 24-MAR-09
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DIGITAL RETINAL CAMERA, CR-1 MARK II
CANON, INC. 510(k) NO: K090466(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 23-MAR-09
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
CARDINAL HEALTH, INC. 510(k) NO: K090272(TRADITIONAL)
ATTN: GINA RAJTEROWSKI PHONE NO : 847-578-6442
1430 WAUKEGAN ROAD- MPKB-2B SE DECISION MADE: 18-MAR-09
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K090521(SPECIAL)
ATTN: DAVID BROOKE PHONE NO : 651-259-2061
651 CAMPUS DR. SE DECISION MADE: 20-MAR-09
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORUM
CARL ZEISS MEDITEC, INC. 510(k) NO: K090439(TRADITIONAL)
ATTN: KENT W JONES PHONE NO : 925-557-4353
5160 HACIENDA DRIVE SE DECISION MADE: 25-MAR-09
DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PHASEAL PROTECTOR P14, P21, P28 AND P50
CARMEL PHARMA AB. 510(k) NO: K090634(SPECIAL)
ATTN: KJELL ANDREASSON PHONE NO : 46 31 7030400
AMINOGATAN 30, MOLNDAL SE DECISION MADE: 23-MAR-09
BOX 5352 510(k) SUMMARY AVAILABLE FROM FDA
GOTHENBURG, SWEDEN SE 402 28
DEVICE: FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC20
CAS MEDICAL SYSTEMS, INC. 510(k) NO: K083892(TRADITIONAL)
ATTN: RON JEFFREY PHONE NO : 203-488-6056
44 EAST INDUSTRIAL RD. SE DECISION MADE: 19-MAR-09
BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
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: 04-MAR-09
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
SCOTTSDALE, AZ 85260
DEVICE: APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 2
CAYENNE MEDICAL, INC. 510(k) NO: K083612(TRADITIONAL)
ATTN: KERESHMEH SHAHRIARI PHONE NO : 480-502-3661
16597 N. 92ND STREET SE DECISION MADE: 04-MAR-09
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
SCOTTSDALE, AZ 85260
DEVICE: DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY,
CHANG GUNG MEDICAL SUPPLIES & EQUI510(k) NO: K090229(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1302
7263 CRONIN CIRCLE SE DECISION MADE: 13-MAR-09
DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHER
CHATTANOOGA GROUP 510(k) NO: K083433(TRADITIONAL)
ATTN: MICHAEL TREAS PHONE NO : 423-870-2281
4717 ADAMS RD. SE DECISION MADE: 18-MAR-09
HIXSON, TN 37343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFTSEAL-STF
CHITOGEN, INC. 510(k) NO: K090100(TRADITIONAL)
ATTN: JANNA BEREUTER PHONE NO : 952-229-8897
7255 OHMS LANE SE DECISION MADE: 11-MAR-09
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REEKROSS FAMILY OR OTW PTA CATHETERS
CLEARSTREAM TECHNOLOGIES, LTD. 510(k) NO: K083596(TRADITIONAL)
ATTN: FIONA N MHULLAIN PHONE NO : 353 53 9237111
MOYNE UPPER, ENNISCORTHY SE DECISION MADE: 02-MAR-09
COUNTY WEXFORD, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CA
CODMAN & SHURTLEFF, INC. 510(k) NO: K090348(SPECIAL)
ATTN: SHARON MCDERMOTT PHONE NO : 508-880-8349
325 PARAMOUNT DR. SE DECISION MADE: 04-MAR-09
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYLATOPIC EMOLLIENT FOAM
COLLEGIUM PHARMACEUTICAL INCORPORA510(k) NO: K083024(TRADITIONAL)
ATTN: RONALD M GURGE PHONE NO : 401-762-2000
400 HIGHLAND CORPORATE DRIVE SE DECISION MADE: 27-MAR-09
CUMBERLAND, RI 02864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPI RAD VISION, MODEL VZW2944XX-YY
COMMUNICATIONS & POWER INDUSTRIES 510(k) NO: K083224(TRADITIONAL)
ATTN: NORM MORIKAWA PHONE NO : 905 877 0161
45 RIVER DRIVE SE DECISION MADE: 24-MAR-09
GEORGETOWN,ONTARIO, CANADA L7G 2J4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
COMMWELL LTD. 510(k) NO: K083677(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 10-MAR-09
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER
CONMED LINVATEC 510(k) NO: K083161(TRADITIONAL)
ATTN: SUE DAUTERMAN PHONE NO : 727-399-5321
11311 CONCEPT BOULEVARD SE DECISION MADE: 27-MAR-09
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURUS SUTURE ANCHORS
CORE ESSENCE ORTHOPAEDICS, INC. 510(k) NO: K090128(SPECIAL)
ATTN: SHAWN T HUXEL PHONE NO : 215-310-9534
301 OXFORD VALLEY RD. SE DECISION MADE: 19-MAR-09
SUITE 905B 510(k) SUMMARY AVAILABLE FROM FDA
YARDLEY, PA 19067
DEVICE: CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
CORPAK MEDSYSTEMS 510(k) NO: K083776(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-403-3484
100 CHADDICK DR. SE DECISION MADE: 05-MAR-09
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
CORPAK MEDSYSTEMS 510(k) NO: K083791(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-403-3484
100 CHADDICK DR. SE DECISION MADE: 04-MAR-09
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: N-600X WITH SPD, OXIMAX N-600X
COVIDIEN 510(k) NO: K083325(TRADITIONAL)
ATTN: SCOTT D DICKERHOFF PHONE NO : 303-305-2382
6135 GUNBARREL AVE. SE DECISION MADE: 09-MAR-09
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILS STITCH ENDOSCOPIC SUTURING DEVICE
COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K090419(SPECIAL)
ATTN: ROBERT ZOTT PHONE NO : 203-492-6013
60 MIDDLETOWN AVENUE SE DECISION MADE: 09-MAR-09
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFIRM CO2 AND AFFIRM CO2 HP
CYNOSURE, INC. 510(k) NO: K081424(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 19-MAR-09
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
CYNOSURE, INC. 510(k) NO: K090235(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 17-MAR-09
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRELUDE ONE
DANVILLE MATERIALS, INC. 510(k) NO: K090106(TRADITIONAL)
ATTN: LINDSAY TILTON PHONE NO : 925-973-0710
3420 FOSTORIA WAY, SUITE A-200 SE DECISION MADE: 31-MAR-09
SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATACOM DC PACS
DATACOM TECHNOLOGY CORP. 510(k) NO: K083182(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58, FU CHIUN STREET SE DECISION MADE: 04-MAR-09
HSIN CHU CITY TW-HSQ TAIWAN, CHINA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DATEX-OHMEDA AISYS
DATEX-OHMEDA, INC. 510(k) NO: K090233(SPECIAL)
ATTN: JIM RASKOB PHONE NO : 608-221-1551
PO BOX 7550 SE DECISION MADE: 05-MAR-09
3030 OHMEDA DR. 510(k) SUMMARY AVAILABLE FROM FDA
MADISON, WI 53707
DEVICE: DEMASQ IMAGING SPFTWARE DEVICE
DEMASQ LIMITED 510(k) NO: K090481(TRADITIONAL)
ATTN: STUART GALL PHONE NO : 441 142 75555
8TH FLOOR EASTGATE HOUSE SE DECISION MADE: 19-MAR-09
34-43 NEWPORT ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CARDIFF WALES, UNITED KINGDOM CF24THIRD PARTY REVIEW
DEVICE: DENOVISMED DENTAL IMPLANT SYSTEMS
DENOVIS MEDICAL, LLC 510(k) NO: K083543(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 06-MAR-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: ALLURE MB CERAMIC BRACKETS
DENTSPLY INTERNTIONAL 510(k) NO: K090454(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-849-4229
221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 20-MAR-09
SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405
DEVICE: GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCO
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K090124(SPECIAL)
ATTN: ZHENG LIU PHONE NO : 508-977-3966
325 PARAMOUNT DR. SE DECISION MADE: 11-MAR-09
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K083642(TRADITIONAL)
ATTN: DAWN SINCLAIR PHONE NO : 574-372-5023
700 ORTHOPAEDIC DR. SE DECISION MADE: 06-MAR-09
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE FISCHER EXTERNAL FIXATION SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K083789(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-6386
700 ORTHOPAEDIC DR. SE DECISION MADE: 23-MAR-09
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K083843(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-6386
700 ORTHOPAEDIC DR. SE DECISION MADE: 20-MAR-09
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 13
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K090374(SPECIAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-6386
700 ORTHOPAEDIC DR. SE DECISION MADE: 11-MAR-09
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K090492(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-6386
700 ORTHOPAEDIC DR. SE DECISION MADE: 31-MAR-09
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K090230(SPECIAL)
ATTN: FRANK JURCZAK PHONE NO : 508-828-3288
325 PARAMOUNT DR. SE DECISION MADE: 06-MAR-09
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVON ACCUBP CUFF
DEVON MEDICAL INC. 510(k) NO: K090664(TRADITIONAL)
ATTN: RUTH WU PHONE NO : 800-251-7488
1100 1ST AVENUE SE DECISION MADE: 23-MAR-09
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
KING OF PRUSSIA, PA 19406 THIRD PARTY REVIEW
DEVICE: ADX4000-L, DX3000-L
DEXCOWIN CO., LTD 510(k) NO: K083532(TRADITIONAL)
ATTN: CLAUDE YANG PHONE NO : 082 256 63360
#708 LE-MEILLEUR TOWN SE DECISION MADE: 10-MAR-09
837-19 GANGNAM-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 135-937
DEVICE: D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K090073(TRADITIONAL)
ATTN: GAIL R GOODRUM PHONE NO : 740-589-3300
1055 EAST STATE STREET SE DECISION MADE: 06-MAR-09
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ATHENS, OH 45701
DEVICE: CARDIUS 3 X-ACT
DIGIRAD CORP. 510(k) NO: K083649(TRADITIONAL)
ATTN: JOEL TUCKEY PHONE NO : 858-726-1600
13950 STOWE DRIVE SE DECISION MADE: 09-MAR-09
POWAY, CA 92064-8803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
DUKAL CORP. 510(k) NO: K083320(TRADITIONAL)
ATTN: JIM VILARDI PHONE NO : 631-656-3800
5 PLANT AVE SE DECISION MADE: 06-MAR-09
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMIPEAK PEAK FLOW METER
DYNAMITECH MEDICAL, INC 510(k) NO: K082899(TRADITIONAL)
ATTN: KEITH LOWREY PHONE NO : 541-476-1628
PACIFIC NORTHWEST BRANCK SE DECISION MADE: 10-MAR-09
611 S. SCHOOLHOUSE CREEK RD 510(k) SUMMARY AVAILABLE FROM FDA
GRANTS PASS, OR 97526
DEVICE: EVERON
EARLYSENSE LTD. 510(k) NO: K082465(TRADITIONAL)
ATTN: DALIA ARGAMAN PHONE NO : 972 3 7522330
12 TZVI STREET SE DECISION MADE: 25-MAR-09
RAMAT GAN, ISRAEL 52504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRO HP PLATFORM
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K082039(TRADITIONAL)
ATTN: ANDREA TOZZI PHONE NO : 055 882 6807
17 VIA BALDANZESE SE DECISION MADE: 20-MAR-09
CALENZANO, ITALY 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMOOTHLIPO
ELEME MEDICAL, INC. 510(k) NO: K083478(TRADITIONAL)
ATTN: MICHAIL PANKRATOV, MD PHONE NO : 603-816-1920
HERON COVE OFFICE PARK SE DECISION MADE: 17-MAR-09
10 AL PAUL LANE, SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
MERRIMACK, NH 03054
DEVICE: REVELATION STEM, MODEL 427-21/42-080/180
ENCORE MEDICAL, L.P. 510(k) NO: K083651(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 13-MAR-09
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
ENDO OPTIKS, INC. 510(k) NO: K083788(TRADITIONAL)
ATTN: DONALD R WATSON PHONE NO : 732-530-6762
39 SYCAMORE AVE. SE DECISION MADE: 03-MAR-09
LITTLE SILVER, NJ 07739-1208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUIVABONE
ETEX CORP. 510(k) NO: K090310(TRADITIONAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 617-577-7270
38 SIDNEY ST., 3FLR SE DECISION MADE: 24-MAR-09
THE CLARK BLDG. 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139
DEVICE: EUROIMMUN ANTI BP 180-4X ELISA (IGG)
EUROIMMUN US INC 510(k) NO: K083615(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973-270-0912
95 WASHINGTON ST SE DECISION MADE: 16-MAR-09
MORRISTOWN, NJ 07960 510(k) STATEMENT
DEVICE: ORBITAL RECONSTRUCTIVE IMPLANT II
EVERA MEDICAL, INC. 510(k) NO: K083342(TRADITIONAL)
ATTN: RANDY KESTEN PHONE NO : 650-525-9750
353 VINTAGE PARK DRIVE SE DECISION MADE: 12-MAR-09
SUITE F 510(k) SUMMARY AVAILABLE FROM FDA
FOSTER CITY, CA 94404
DEVICE: EOI SPINAL SYSTEM
EXPANDING ORTHOPEDICS, INC. 510(k) NO: K083825(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267-675-4611
1835 MARKET STREET SE DECISION MADE: 19-MAR-09
29TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PHILADELPHIA, PA 19103
DEVICE: HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K083122(TRADITIONAL)
ATTN: STEPHANIE COSTE PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 04-MAR-09
P.O. BOX 14348 510(k) SUMMARY AVAILABLE FROM FDA
EAST TAMAKI, NEW ZEALAND
DEVICE: ZEST NASAL MASK
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K083832(TRADITIONAL)
ATTN: TINA MASON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 16-MAR-09
P.O. BOX 14348 510(k) SUMMARY AVAILABLE FROM FDA
EAST TAMAKI, NEW ZEALAND
DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MO
FUKUDA DENSHI USA, INC. 510(k) NO: K083697(TRADITIONAL)
ATTN: DOUG BLAKELY PHONE NO : 425-881-7737
17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 19-MAR-09
REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K083750(SPECIAL)
ATTN: ROBERT L CASARSA PHONE NO : 414-362-3063
8200 WEST TOWER AVE. SE DECISION MADE: 23-MAR-09
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
GENERIC MEDICAL DEVICE, INC. 510(k) NO: K083471(TRADITIONAL)
ATTN: MONICA MONTANEZ PHONE NO : 253-853-3594
5727 BAKER WAY NW STE 201 SE DECISION MADE: 03-MAR-09
GIG HARBOR, WA 98332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COALITION SPACER
GLOBUS MEDICAL INC. 510(k) NO: K083389(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 26-MAR-09
AUDUBON, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K090026(TRADITIONAL)
ATTN: KEVIN HAWKINS PHONE NO : 503-245-0459
10575 SW CASCADE AVENUE SE DECISION MADE: 31-MAR-09
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
PORTLAND, OR 97223-4363
DEVICE: TRUEBALANCE BLOOD GLUCOSE SYSTEM
HOME DIAGNOSTICS, INC. 510(k) NO: K090495(SPECIAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 27-MAR-09
FORT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
HOSPIRA, INC. 510(k) NO: K090610(TRADITIONAL)
ATTN: YULIYA MATLIN PHONE NO : 224-212-4857
275 NORTH FIELD DR. SE DECISION MADE: 13-MAR-09
D-389, BLDG., H2 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045 THIRD PARTY REVIEW
DEVICE: HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
HOVEROUND CORP. 510(k) NO: K090108(TRADITIONAL)
ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200
2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 19-MAR-09
SARASOTA, FL 34243 510(k) STATEMENT
DEVICE: HOYA IS INJECTOR SYSTEM
HOYA SURGICAL OPTICS, INC. 510(k) NO: K081346(TRADITIONAL)
ATTN: STEVEN L ZIEMBA PHONE NO : 909-680-3922
14768 PIPELINE AVE. SE DECISION MADE: 23-MAR-09
CHINO HILLS, CA 91709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024
ICAD, INC. 510(k) NO: K090223(TRADITIONAL)
ATTN: JOHN A DELUCIA PHONE NO : 937-431-7945
98 SPIT BROOK ROAD SE DECISION MADE: 31-MAR-09
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
NASHUA, NH 03062
DEVICE: INCLUSIVE TITANIUM ABUTMENT BLANKS
INCLUSIVE DENTAL SOLUTIONS 510(k) NO: K083192(ABBREVIATED)
ATTN: KEITH D ALLRED PHONE NO : 949-440-2683
4141 MACARTHUR BLVD SE DECISION MADE: 04-MAR-09
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVIRO SHARP SOLUTIONS 3
INDUSTRIAL WATER SOLUTIONS, INC 510(k) NO: K083511(TRADITIONAL)
ATTN: THOMAS P STEWART PHONE NO : 540-772-0599
2692 WILLOWLAWN STREET SE DECISION MADE: 03-MAR-09
ROANOKE, VA 24018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOBAND, MODELS HB-NS AND HB-NSXL
INNOVATIONS FOR ACCESS, INC. 510(k) NO: K081740(TRADITIONAL)
ATTN: HAL J OIEN PHONE NO : 800-297-8485
515 NW SALTZMAN ROAD #797 SE DECISION MADE: 12-MAR-09
PORTLAND, OR 97229-6098 510(k) STATEMENT
DEVICE: BLACK NITRILE EXAMINATION GLOVES
INNOVATIVE GLOVES CO; LTD 510(k) NO: K083908(TRADITIONAL)
ATTN: RAJEEV K SOOD PHONE NO : 66 742 40132
830 MOO 4 SANAMBIN-BANKLANG RD SE DECISION MADE: 06-MAR-09
TAMBON KUANLANG, AMPHUR HATYAI 510(k) SUMMARY AVAILABLE FROM FDA
SONGKHLA, THAILAND 90110
DEVICE: CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
INSPIRED TECHNOLOGIES, INC. 510(k) NO: K082853(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 23-MAR-09
BONITA SPRINGS, FL 34134-2958 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CO
INSTRUMENTATION LABORATORY CO. 510(k) NO: K083518(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 13-MAR-09
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIONICS XKNIFE HDRT SYSTEM
INTEGRA RADIONICS, INC. 510(k) NO: K083414(TRADITIONAL)
ATTN: KEVIN O'CONNELL PHONE NO : 781-565-1227
22 TERRY AVENUE SE DECISION MADE: 02-MAR-09
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODYMETRIX BX2000
INTELAMETRIX, INC 510(k) NO: K082147(TRADITIONAL)
ATTN: HEIDI STARK PHONE NO : 925-606-7044
6246 PRESTON AVENUE SE DECISION MADE: 20-MAR-09
LIVERMORE, CA 94551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SECURACATH, MODEL: SPK01
INTERRAD MEDICAL, INC. 510(k) NO: K083081(TRADITIONAL)
ATTN: SEW-WAH TAY PHONE NO : 612-801-6782
18555 37TH AVE N SE DECISION MADE: 04-MAR-09
PLYMOUTH, MN 55446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
INVATEC INNOVATIVE TECHNOLOGIES, S510(k) NO: K083919(TRADITIONAL)
ATTN: STEVE CAMP PHONE NO : 610-625-1402
3101 EMRICK BLVD SE DECISION MADE: 13-MAR-09
SUITE 113 510(k) SUMMARY AVAILABLE FROM FDA
BETHLEHEM, PA 18020
DEVICE: MESA SPINAL SYSTEM
K2M, INC. 510(k) NO: K080611(SPECIAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 04-MAR-09
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K080852(TRADITIONAL)
ATTN: CRYSTAL DIZOL PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 30-MAR-09
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CAN
KCI USA, INC. 510(k) NO: K083357(TRADITIONAL)
ATTN: CHRISTY H OVIATT PHONE NO : 210-255-6105
6203 FARINON DR. SE DECISION MADE: 04-MAR-09
SAN ANTONIO, TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HAND
KFX MEDICAL 510(k) NO: K083609(TRADITIONAL)
ATTN: GAYLE HIROTA PHONE NO : 760-444-8844
5845 AVENIDA ENCINAS,SUITE 128 SE DECISION MADE: 06-MAR-09
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
KHN SOLUTIONS, LLC 510(k) NO: K083801(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 19-MAR-09
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACTRACK SELECT BREATHALYZER, MODEL S80
KHN SOLUTIONS, LLC 510(k) NO: K090067(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 24-MAR-09
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMGUARD ONE-STEP STERILIZATION WRAP
KIMBERLY-CLARK CORP. 510(k) NO: K082177(TRADITIONAL)
ATTN: LISA PEACOCK PHONE NO : 706-216-3413
172 CONDUCTOR DRIVE SE DECISION MADE: 27-MAR-09
DAWSONVILLE, GA 30534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLA
KIMBERLY-CLARK CORP. 510(k) NO: K083234(TRADITIONAL)
ATTN: LISA PEACOCK PHONE NO : 706-216-3413
172 CONDUCTOR DRIVE SE DECISION MADE: 25-MAR-09
DAWSONVILLE, GA 30534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRILL FREE MMF SCREW
KLS MARTIN L.P. 510(k) NO: K083432(TRADITIONAL)
ATTN: TOM FAUCET PHONE NO : 904-641-7746
11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 31-MAR-09
PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: EVOX ELECTRO DIAGNOSTIC DEVICE
LABORIE MEDICAL TECHNOLOGIES, INC.510(k) NO: K082614(TRADITIONAL)
ATTN: BARBARA MORNET PHONE NO : 802-857-1300
400 AVENUE D SUITE 10 SE DECISION MADE: 06-MAR-09
WILLISTON, VT 05495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
LANX, INC. 510(k) NO: K090252(SPECIAL)
ATTN: ANDREW LAMBORNE PHONE NO : 303-443-7500
390 INTERLOCKEN CRESCENT SE DECISION MADE: 04-MAR-09
SUITE 890 510(k) SUMMARY AVAILABLE FROM FDA
BROOMFIELD, CO 80021
DEVICE: LOUSEBUSTER
LARADA SCIENCES 510(k) NO: K083206(TRADITIONAL)
ATTN: PHIL TRIOLO PHONE NO : 801-699-9846
148 S. 1200 E. SE DECISION MADE: 10-MAR-09
SALT LAKE CITY, UT 84102-1643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL INJECTION SYSTEM
LAURIMED LLC 510(k) NO: K083909(TRADITIONAL)
ATTN: SEVRINA CIUCCI PHONE NO : 408-316-4837
500 ARGUELLO STREET, SUITE 100 SE DECISION MADE: 18-MAR-09
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
MAINE STANDARDS CO. 510(k) NO: K083891(TRADITIONAL)
ATTN: HOLLY CRESSMAN PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 23-MAR-09
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIE A1C TEST SYSTEM
MEC DYNAMICS CORP 510(k) NO: K081269(TRADITIONAL)
ATTN: EMMANUEL MPOCK PHONE NO : 408-844-9279
2225 MARTIN AVE SE DECISION MADE: 20-MAR-09
SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95050
DEVICE: MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C
MEDACTA INTERNATIONAL, SA 510(k) NO: K083558(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858-705-0350
13721 VIA TRES VISTA SE DECISION MADE: 06-MAR-09
SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE MEDCOMP .010" VASCULAR GUIDEWIRES
MEDCOMP 510(k) NO: K081775(TRADITIONAL)
ATTN: LISA WEIKERT PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 25-MAR-09
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-0
MEDI-GLOBE CORPORATION 510(k) NO: K083802(TRADITIONAL)
ATTN: SCOTT KARLER PHONE NO : 480-897-2772
110 WEST ORION ST #136 SE DECISION MADE: 20-MAR-09
TEMPE, AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KI
MEDICA CORP. 510(k) NO: K080404(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892
5 OAK PARK DRIVE SE DECISION MADE: 13-MAR-09
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: MORTARA STRESS ECHO BED
MEDICAL POSITIONING, INC. 510(k) NO: K082967(SPECIAL)
ATTN: CAROL WHITE PHONE NO : 949-589-0442
21521 HUMMINGBIRD STREET SE DECISION MADE: 26-MAR-09
TRABUCO CANYON, CA 92679 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-05
MEDSHAPE SOLUTIONS 510(k) NO: K083792(TRADITIONAL)
ATTN: JACK GRIFFIS PHONE NO : 404-249-9156
1575 NORTHSIDE DR. SE DECISION MADE: 25-MAR-09
SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30318
DEVICE: ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHET
MEDTRONIC INC. 510(k) NO: K090659(SPECIAL)
ATTN: BRUCE BACKLUND PHONE NO : 763-526-2357
8200 CORAL SEA ST NE SE DECISION MADE: 26-MAR-09
MS:MVS11 510(k) SUMMARY AVAILABLE FROM FDA
MOUNDS VIEW, MN 55112
DEVICE: MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710,
MEDTRONIC POWERED SURGICAL SOLUTIO510(k) NO: K090112(TRADITIONAL)
ATTN: JEFFERY HENDERSON PHONE NO : 817-788-6400
4620 NORTH BEACH ST. SE DECISION MADE: 26-MAR-09
FORT WORTH, TX 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCURY MEDICAL PEEP VALVE
MERCURY ENTERPRIZES DBA MERCURY ME510(k) NO: K081266(TRADITIONAL)
ATTN: BRIAN L MORRISON PHONE NO : 727-573-0088
11300 49TH STREET NORTH SE DECISION MADE: 05-MAR-09
CLEARWATER, FL 33762 510(k) STATEMENT
DEVICE: TRACH-ASSIST
MERGENET MEDICAL 510(k) NO: K083702(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 05-MAR-09
BONITA SPRINGS, FL 34134-2958 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSIN
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K090084(TRADITIONAL)
ATTN: SUSAN SCOTT PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 06-MAR-09
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
MICROVENTION, INC. 510(k) NO: K090001(SPECIAL)
ATTN: NAOMI GONG PHONE NO : 949-461-3314
75 COLUMBIA SE DECISION MADE: 05-MAR-09
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
ALISO VIEJO, CA 92656-1408
DEVICE: AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-4
MICROVENTION, INC. 510(k) NO: K090168(SPECIAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-951-0516
75 COLUMBIA SE DECISION MADE: 12-MAR-09
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K090274(SPECIAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1428
821 FOX LANE SE DECISION MADE: 03-MAR-09
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64
MIDWEST R.F. LLC. 510(k) NO: K090267(TRADITIONAL)
ATTN: DAVID M PETERSON PHONE NO : 262-367-6925
1015 WALNUT RIDGE DRIVE SE DECISION MADE: 16-MAR-09
PO BOX 348 510(k) STATEMENT
HARTLAND, WI 53029
DEVICE: MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MIL
MILTEX, INC. 510(k) NO: K083796(TRADITIONAL)
ATTN: JENNIFER J BOSLEY PHONE NO : 717-781-6392
589 DAVIES DRIVE SE DECISION MADE: 09-MAR-09
YORK, PA 17402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
MIRAMAR LABS, INC. 510(k) NO: K082819(TRADITIONAL)
ATTN: KATHY O'SHAUGHNESSY PHONE NO : 650-326-2656
199 JEFFERSON DR. SE DECISION MADE: 20-MAR-09
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFAST HSCRP
MITSUBISHI KAGAKU IATRON 510(k) NO: K083412(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7363
701 FIFTH AVENUE SE DECISION MADE: 09-MAR-09
FLOOR 42 510(k) STATEMENT
SEATTLE, WA 98104
DEVICE: CIRRUS OPEN
MRI-TECH SP. ZO.O. 510(k) NO: K090080(TRADITIONAL)
ATTN: ANITA CHAN PHONE NO : 778 288 1698
206 - 3820 CAMBIE STREET SE DECISION MADE: 23-MAR-09
VANCOUVER, BC, CANADA V5Z 2X7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRITICOOL
MTRE ADVANCED TECHNOLOGY LTD. 510(k) NO: K083662(TRADITIONAL)
ATTN: IFAT OREN PHONE NO : 972 893 23333
4 HA-YARDEN ST. SE DECISION MADE: 26-MAR-09
(P.O.BOX 102 REHOVOT 76100) 510(k) SUMMARY AVAILABLE FROM FDA
YAVNE, ISRAEL 81228
DEVICE: MYOSCIENCE CRYO-TOUCH
MYOSCIENCE INC 510(k) NO: K083493(TRADITIONAL)
ATTN: TRACEY HENRY PHONE NO : 650-474-2600
525 CHESAPEAKE DRIVE SE DECISION MADE: 20-MAR-09
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BETACHEK GLUCOSE TEST
NATIONAL DIAGNOSTIC PRODUCTS 510(k) NO: K062187(TRADITIONAL)
ATTN: BRANDON STEPHEN BRANSGROVE PHONE NO : 61 294 1847
7-9 MERRIWA ST. SE DECISION MADE: 24-MAR-09
GORDON 510(k) SUMMARY AVAILABLE FROM FDA
SYDNEY, AUSTRALIA 2072
DEVICE: NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER
NAVISCAN, INC. 510(k) NO: K090553(SPECIAL)
ATTN: HEATHER JALISI PHONE NO : 858-332-0942
6865 FLANDERS DRIVE SE DECISION MADE: 31-MAR-09
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: NEOSS ACCESS ABUTMENTS
NEOSS, LTD. 510(k) NO: K081851(TRADITIONAL)
ATTN: FREDRIK ENGMAN PHONE NO : 440 142 3817733
WINDSOR HOUSE, CORNWALL RD. SE DECISION MADE: 02-MAR-09
HARROGATE, YORKSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROCARE
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K090552(TRADITIONAL)
ATTN: TIAN YANFANG PHONE NO : 862 483 660649
NO. 16, SHIJI ROAD SE DECISION MADE: 16-MAR-09
HUNNAN INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110179 THIRD PARTY REVIEW
DEVICE: COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
NEW STAR LASERS, INC. 510(k) NO: K090410(SPECIAL)
ATTN: NATALIE R VOLLRATH PHONE NO : 916-677-1900
9085 FOOTHILLS BLVD. SE DECISION MADE: 27-MAR-09
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
NIHON KOHDEN AMERICA, INC. 510(k) NO: K083456(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 02-MAR-09
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS A
NIKKISO CO. LTD. 510(k) NO: K082719(TRADITIONAL)
ATTN: FUMIAKI KANAI PHONE NO : 011 813 38188577
4-2-1 YUSHIMA SE DECISION MADE: 30-MAR-09
BUNKYO-KU 510(k) SUMMARY AVAILABLE FROM FDA
TOKYO, JAPAN 113-0034
DEVICE: BIOCLEAN CHEMO SHIELD
NITRITEX (M) SDN. BHD. 510(k) NO: K081970(TRADITIONAL)
ATTN: DEREK WATTS PHONE NO : 603 312 22614
KEBUN BARU, JLN MASJID SE DECISION MADE: 11-MAR-09
TELOK PANGLIMA GARANG 510(k) SUMMARY AVAILABLE FROM FDA
KUALA LANGAT, SELANGOR DE, MALAYSIA 42500
DEVICE: SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
NOBLE ANESTHESIA-AIR, INC. 510(k) NO: K082528(TRADITIONAL)
ATTN: ALEXANDER B HENDERSON PHONE NO : 303-646-3715
277 ZANE COURT SE DECISION MADE: 06-MAR-09
HILLSIDE VILLAGE 510(k) SUMMARY AVAILABLE FROM FDA
ELIZABETH, CO 80107
DEVICE: NUVASIVE HELIX-T ACP SYSTEM
NUVASIVE, INC. 510(k) NO: K083341(SPECIAL)
ATTN: HAN FAN PHONE NO : 858-909-3338
7475 LUSK BLVD SE DECISION MADE: 20-MAR-09
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
O-TWO MEDICAL TECHNOLOGIES, INC. 510(k) NO: K081330(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 06-MAR-09
BONITA SPRINGS, FL 34134-2958 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OKAMOTO ULTRA THIN
OKAMOTO U.S.A., INC. 510(k) NO: K090259(ABBREVIATED)
ATTN: JEFFERY N GIBBS PHONE NO : 202-737-4288
700 THIRTEENTH STREET, N.W. SE DECISION MADE: 31-MAR-09
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
OLYMPUS AMERICA, INC. 510(k) NO: K081615(TRADITIONAL)
ATTN: STEPHANIE G DONNELLY PHONE NO : 469 230 0959
LISHEEHAN, O'CALLAGHAN'S MILLS SE DECISION MADE: 18-MAR-09
CO. CLARE, IRELAND 510(k) STATEMENT
DEVICE: OLYMPUS AFP - ALPHA-FETOPROTEIN
OLYMPUS LIFE SCIENCE RESEARCH EURO510(k) NO: K081709(TRADITIONAL)
ATTN: STEPHANIE G DONNELLY PHONE NO : 469 230 0959
LISMEEHAN SE DECISION MADE: 16-MAR-09
O'CALLAGHANS MILLS, CO. CLARE, IRE510(k) STATEMENT
DEVICE: CLEARVUE PRONE BREAST TREATMENT TABLE
ORBITAL THERAPY, LLC 510(k) NO: K090349(TRADITIONAL)
ATTN: CHAS BURR PHONE NO : 781-789-1646
11 MYSTIC AVENUE SE DECISION MADE: 09-MAR-09
WINCHESTER, MA 01890 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDINAIL INTRAMEDULLARY NAILING SYSTEM
ORTHOPEDIATRICS, CORP. 510(k) NO: K083726(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574-268-6379
210 N. BUFFALO ST. SE DECISION MADE: 11-MAR-09
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSCAR BONE RESECTOR
ORTHOSONICS, LTD. 510(k) NO: K083830(TRADITIONAL)
ATTN: MICHAEL J YOUNG PHONE NO : 44 136 4652426
BREMRIDGE HOUSE SE DECISION MADE: 20-MAR-09
ASHBURTON, DEVON, UNITED KINGDOM T510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: DSS STABILIZATION SYSTEM
PARADIGM SPINE, LLC 510(k) NO: K090408(SPECIAL)
ATTN: ADAM HERDER PHONE NO : 202-552-5819
1331 H STREET NW SE DECISION MADE: 20-MAR-09
12TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-
PARCUS MEDICAL, LLC 510(k) NO: K083619(TRADITIONAL)
ATTN: BARTON BRACY PHONE NO : 920-746-8661
839 SOUTH NEENAH AVE. SE DECISION MADE: 06-MAR-09
STURGEON BAY, WI 54235 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257,
PARCUS MEDICAL, LLC 510(k) NO: K090075(TRADITIONAL)
ATTN: BARTON BRACY PHONE NO : 920-746-2972
839 SOUTH NEENAH AVE. SE DECISION MADE: 06-MAR-09
STURGEON BAY, WI 54235 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH
PASCAL CO., INC. 510(k) NO: K090597(SPECIAL)
ATTN: VINCENT M TENTARELLI PHONE NO : 425-602-3633
2929 N.E. NORTHUP WAY SE DECISION MADE: 16-MAR-09
BELLEVUE, WA 98004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND C
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K090325(SPECIAL)
ATTN: BRIT BAIRD PHONE NO : 425-636-4137
10801 120TH AVENUE NE SE DECISION MADE: 11-MAR-09
KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICC (CT RATED AND NON-RATED)
PFM MEDICAL, INC 510(k) NO: K083873(TRADITIONAL)
ATTN: SALVADORE PALOMARES PHONE NO : 760-758-8749
2605 TEMPLE HEIGHTS DRIVE SE DECISION MADE: 19-MAR-09
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
OCEANSIDE, CA 92056
DEVICE: IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUN
PHADIA AB 510(k) NO: K081830(TRADITIONAL)
ATTN: MARTIN MANN PHONE NO : 269-492-1957
4169 COMMERCIAL AVENUE SE DECISION MADE: 16-MAR-09
PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA RECOMBI ANA SCREEN, MODEL 12 596
PHADIA US INC. 510(k) NO: K083188(TRADITIONAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957
4169 COMMERCIAL AVE. SE DECISION MADE: 13-MAR-09
PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONI
PHILIPS MEDICAL SYSTEMS 510(k) NO: K090483(SPECIAL)
ATTN: LARRY MILANA PHONE NO : 978-659-7860
3000 MINUTEMAN RD. SE DECISION MADE: 20-MAR-09
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERADIUS, MODEL 718-130
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K090590(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 16-MAR-09
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003 THIRD PARTY REVIEW
DEVICE: WIRELESS PORTABLE DETECTOR FD-W17
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K090625(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 24-MAR-09
BOTHELL, WA 98041-3003 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AUTOSPECT
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K090403(TRADITIONAL)
ATTN: ROBERT Z PHILLIPS PHONE NO : 440-483-2100
595 MINER RD. SE DECISION MADE: 31-MAR-09
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEPAK 15 MONITOR/DEFIBRILLATOR
PHYSIO-CONTROL, INC. 510(k) NO: K082937(TRADITIONAL)
ATTN: TERESA DAVIDSON PHONE NO : 425-867-4733
11811 WILLOWS RD., N.E. SE DECISION MADE: 11-MAR-09
PO BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98052
DEVICE: GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV
PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K090524(SPECIAL)
ATTN: THOMAS J SCHAPPERT PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE. SE DECISION MADE: 19-MAR-09
EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM
PRISM CLINICAL IMAGING, INC. 510(k) NO: K082964(TRADITIONAL)
ATTN: JAMES L REUSS PHONE NO : 414-727-1930
851 S. 70TH ST., SUITE 103 SE DECISION MADE: 09-MAR-09
WEST ALLIS, WI 53214 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE PFT FILTER
PULMONARY FILTRATION TECHNOLOGIES 510(k) NO: K083233(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 02-MAR-09
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
PULMONETIC SYSTEMS, INC. 510(k) NO: K083688(TRADITIONAL)
ATTN: ROBERT C SAMEC PHONE NO : 763-398-8305
17400 MEDINA ROAD SE DECISION MADE: 18-MAR-09
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55447
DEVICE: CARDIOVIEW32 REVIEW MODULE
QRS DIAGNOSTIC, LLC. 510(k) NO: K083749(SPECIAL)
ATTN: MARY KAY JENSEN PHONE NO : 763-559-8492
14755 27TH AVE.NORTH SE DECISION MADE: 10-MAR-09
PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100
QUANTA COMPUTER INC. 510(k) NO: K083079(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
2904 N. BOLDT DR. SE DECISION MADE: 05-MAR-09
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
QUANTEL MEDICAL 510(k) NO: K081946(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 25-MAR-09
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
R4 VASCULAR, INC. 510(k) NO: K083763(TRADITIONAL)
ATTN: LAURIE LEWANDOWSKI PHONE NO : 763-494-8400
7550 MERIDIAN CIR. N SE DECISION MADE: 16-MAR-09
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANCE SPINAL SCREW SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K081978(TRADITIONAL)
ATTN: BRET M BERRY PHONE NO : 801-718-7467
2647 CASSOWARY CIR SE DECISION MADE: 26-MAR-09
SANDY, UT 84092-7116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMESENSE
REMEDENT NV 510(k) NO: K082594(TRADITIONAL)
ATTN: WILLIAM GREENROSE PHONE NO : 603-369-3550
220 RIVER ROAD SE DECISION MADE: 19-MAR-09
CLAREMONT, NH 03743 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APNEALINK PLUS, MODEL: 22328
RESMED GERMANY INC. 510(k) NO: K083575(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 19-MAR-09
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RES TRAXX ONLINE, MODEL: R14
RESMED LTD. 510(k) NO: K083816(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 20-MAR-09
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILOGY 100 VENTILATOR
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K083526(ABBREVIATED)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1740 GOLDEN MILE HWY SE DECISION MADE: 13-MAR-09
MONROEVILLE, PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP AUTOSV
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K090248(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 04-MAR-09
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORTLITE NASAL MASK
RESPIRONICS, INC. 510(k) NO: K082558(TRADITIONAL)
ATTN: ANDREW ZELTWANGER PHONE NO : 724-448-0543
1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 25-MAR-09
MONROEVILLE, PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-REACTIVE PROTEIN (LATEX)
ROCHE DIAGNOSTICS CORP. 510(k) NO: K083444(TRADITIONAL)
ATTN: KATHIE J GOODWIN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 18-MAR-09
PO BOX 50416 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0416
DEVICE: ROOT CANAL XR
S & C POLYMER GMBH 510(k) NO: K083062(TRADITIONAL)
ATTN: CHRISTIAN BOETTCHER PHONE NO : 004 9 41214830
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 12-MAR-09
ELMSHORN, GERMANY D-25335 510(k) STATEMENT
DEVICE: PHOGLASS CEM
S & C POLYMER GMBH 510(k) NO: K083766(TRADITIONAL)
ATTN: CHRISTIAN BOETTCHER PHONE NO : 004 941 214830
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 02-MAR-09
ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
SEBIA 510(k) NO: K082227(TRADITIONAL)
ATTN: KAREN ANDERSON PHONE NO : 770-446-3707
400-1705 CORPORATE DRIVE SE DECISION MADE: 26-MAR-09
SUITE 400 510(k) STATEMENT
NORCROSS, GA 30093
DEVICE: SEDECAL, MILLENNIUM PLUS
SEDECAL S.A. 510(k) NO: K090279(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
333 MILFORD ROAD SE DECISION MADE: 11-MAR-09
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY MOVING PLUS, SM-XXHF-YY
SEDECAL S.A. 510(k) NO: K090322(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
333 MILFORD ROAD SE DECISION MADE: 17-MAR-09
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERIM DISINTEK GTA 2.1%, MODEL: 5164
SERIM RESEARCH CORP. 510(k) NO: K083295(TRADITIONAL)
ATTN: PATRICIA RUPCHOCK PHONE NO : 574-264-3440
3506 REEDY DR. SE DECISION MADE: 16-MAR-09
ELKHART, IN 46561 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA,
SHANDONG WEIGAO MEDICAL POLYMER CO510(k) NO: K082439(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
SUITE 8D, NO.19, LANE 999, SE DECISION MADE: 23-MAR-09
ZHONGSHAN NO.2 ROAD(S) 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
SHAPE MEDICAL SYSTEMS, INC 510(k) NO: K090722(TRADITIONAL)
ATTN: CLARENCE JOHNSON PHONE NO : 612-455-0550
1313 5TH AVE. SE SE DECISION MADE: 31-MAR-09
SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55414 THIRD PARTY REVIEW
DEVICE: STONE GRASPING BASKET, MODEL PD-T1 2115
SIALO TECHNOLOGY, LTD. 510(k) NO: K082735(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002
20 HATA'AS ST. SE DECISION MADE: 13-MAR-09
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLU
SIAM SEMPERMED CORP. LTD. 510(k) NO: K083755(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250
13900 49TH STREET NORTH SE DECISION MADE: 05-MAR-09
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083314(TRADITIONAL)
ATTN: CLARE SANTULLI PHONE NO : 914-524-2701
511 BENEDICT AVENUE SE DECISION MADE: 11-MAR-09
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T P
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083445(TRADITIONAL)
ATTN: HELEN M LEE PHONE NO : 302-631-8706
500 GBC DRIVE M/S 514 SE DECISION MADE: 24-MAR-09
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083463(TRADITIONAL)
ATTN: ANNA M KATHLEEN ENNIS PHONE NO : 302-631-9352
500 GBC DRIVE SE DECISION MADE: 13-MAR-09
PO BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATM
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083487(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
MS 514, PO BOX 6101 SE DECISION MADE: 30-MAR-09
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083853(TRADITIONAL)
ATTN: CLARE SANTULLI PHONE NO : 914-524-2701
511 BENEDICT AVENUE SE DECISION MADE: 24-MAR-09
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C C
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083906(TRADITIONAL)
ATTN: KIRA GORDON PHONE NO : 914-524-2996
511 BENEDICT AVENUE SE DECISION MADE: 11-MAR-09
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K083339(TRADITIONAL)
ATTN: LUBOMYR SHCHUR PHONE NO : 914-524-2091
511 BENEDICT AVENUE SE DECISION MADE: 09-MAR-09
TARRYTOWN, NY 10509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON P50 ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K083114(SPECIAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 31-MAR-09
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: BIOGRAPH 16 TRUE POINT SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K083852(TRADITIONAL)
ATTN: ALAINE MEDIO PHONE NO : 865-218-2703
810 INNOVATION DRIVE SE DECISION MADE: 23-MAR-09
KNOXVILLE, TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004
SIMPLER ONE STOP 510(k) NO: K083886(TRADITIONAL)
ATTN: HAROLD BERGMAN PHONE NO : 604 736 9890
1023 WOLFE AVE SE DECISION MADE: 23-MAR-09
#404 510(k) SUMMARY AVAILABLE FROM FDA
VANCOUVER, BC, CANADA V6H 1V6
DEVICE: ZQUIET MOUTHPIECE
SLEEPING WELL, LLC 510(k) NO: K090503(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
1468 HARWELL AVE. SE DECISION MADE: 10-MAR-09
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: R3 CONSTRAINED LINER, CONSTRAINED LINER
SMITH & NEPHEW, INC. 510(k) NO: K083566(TRADITIONAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520
1450 BROOKS RD. SE DECISION MADE: 03-MAR-09
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOX DELTA CERAMIC FEMORAL HEADS
SMITH & NEPHEW, INC. 510(k) NO: K083762(SPECIAL)
ATTN: MANDY COE PHONE NO : 901-399-6277
1450 BROOKS RD. SE DECISION MADE: 11-MAR-09
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIGALILEO TKR BASE V2.3 AND CAS V4.1
SMITH & NEPHEW, INC. 510(k) NO: K090313(SPECIAL)
ATTN: MANDY COE PHONE NO : 901-399-6277
1450 BROOKS RD. SE DECISION MADE: 11-MAR-09
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW INSTRUMENT TRAYS
SMITH & NEPHEW, INC. 510(k) NO: K090562(SPECIAL)
ATTN: JULIE ACKER PHONE NO : 508-261-3618
130 FORBES BLVD. SE DECISION MADE: 18-MAR-09
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND
SMITHS MEDICAL ASD, INC. 510(k) NO: K083451(TRADITIONAL)
ATTN: CYNTHIA ENGELHARDT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 04-MAR-09
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
SPECTRA MEDICAL DEVICES, INC. 510(k) NO: K082689(TRADITIONAL)
ATTN: DAVID L ROSEN PHONE NO : 202-672-5430
3000 K ST., NW SE DECISION MADE: 20-MAR-09
WASHINGTON, DC 20007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED EXTERNAL FIXATION DEVICE
STERILMED, INC. 510(k) NO: K083636(TRADITIONAL)
ATTN: GARRETT AHLBORG PHONE NO : 763-488-3483
11400 73RD AVE. NORTH, #100 SE DECISION MADE: 02-MAR-09
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIS CMAX XLT SURGICAL TABLE
STERIS CORPORATION 510(k) NO: K090136(TRADITIONAL)
ATTN: JOHN ROBERT SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 20-MAR-09
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2)
STERIS CORPORATION 510(k) NO: K090514(SPECIAL)
ATTN: JOHN R SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 16-MAR-09
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMU-GRAPH 4 EMULATOR, MODEL CI 144
STERITEC PRODUCTS, INC. 510(k) NO: K083650(SPECIAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4213
599 TOPEKA WAY, SUITE 400 SE DECISION MADE: 05-MAR-09
CASTLE ROCK, CO 80109 510(k) STATEMENT
DEVICE: STAK-CHEX PLUS RETICS
STRECK 510(k) NO: K090137(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 402-537-5215
7002 SOUTH 109TH ST. SE DECISION MADE: 18-MAR-09
OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UA-CELLULAR FOR IQ
STRECK 510(k) NO: K090201(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 402-537-5215
7002 SOUTH 109TH ST. SE DECISION MADE: 27-MAR-09
OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYS
STRYKER CORP. 510(k) NO: K083020(SPECIAL)
ATTN: KIMBERLY LANE PHONE NO : 201-760-8215
2 PEARL COURT SE DECISION MADE: 26-MAR-09
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM
STRYKER CORP. 510(k) NO: K083562(TRADITIONAL)
ATTN: KIMBERLY LANE PHONE NO : 201-760-8215
2 PEARL COURT SE DECISION MADE: 25-MAR-09
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEDOP MODEL, L350R
SUMMIT DOPPLER SYSTEMS, INC. 510(k) NO: K090499(TRADITIONAL)
ATTN: KEN JARRELL PHONE NO : 303-423-7572
4680 TABLE MOUNTAIN DR #150 SE DECISION MADE: 31-MAR-09
GOLDEN, CO 80403 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
SURGICAL DEVICES, TYCO HEALTHCARE 510(k) NO: K082662(TRADITIONAL)
ATTN: RENEE BORGESANO PHONE NO : 203-492-5325
60 MIDDLETOWN AVE. SE DECISION MADE: 26-MAR-09
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMCARE DIABETES MANAGEMENT PROGRAM
SYMCARE PERSONALIZED HEALTH SOLUTI510(k) NO: K083263(TRADITIONAL)
ATTN: RAE ANN DELAY PHONE NO : 484-686-4650
200 LAWRENCE DRIVE SE DECISION MADE: 13-MAR-09
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHASOME X-REPAIR
SYNTHASOME, INC. 510(k) NO: K083307(TRADITIONAL)
ATTN: ANTHONY RATCLIFFE PHONE NO : 858-490-9400
3030 BUNKER HILL ST. SE DECISION MADE: 27-MAR-09
SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92109
DEVICE: SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
SYNTHES (USA) 510(k) NO: K083388(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 610-719-6290
1301 GOSHEN PKWY. SE DECISION MADE: 12-MAR-09
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
SYNTHES (USA) 510(k) NO: K083573(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-719-6941
1301 GOSHEN PKWY. SE DECISION MADE: 04-MAR-09
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATE
SYNTHES (USA) 510(k) NO: K083694(TRADITIONAL)
ATTN: SHERI L MUSGUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY. SE DECISION MADE: 06-MAR-09
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K083570(SPECIAL)
ATTN: SOPHIE LIN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 11-MAR-09
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K090395(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 10-MAR-09
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-424
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K090536(SPECIAL)
ATTN: SOPHIE LIN PHONE NO : 886 2 66258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 26-MAR-09
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 248
DEVICE: BEL-CYPHER, MODEL Y977
TAKARA-BELMONT CO., LTD. 510(k) NO: K090020(TRADITIONAL)
ATTN: KUNIHIKO SOBUE PHONE NO : 732-469-5000
101 BELMONT DRIVE SE DECISION MADE: 13-MAR-09
SOMERSET, NJ 08873-1204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED
TANGSHAN JITENG PLASTIC PRODUCTS C510(k) NO: K090537(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
RM 1606 BLDG 1 SE DECISION MADE: 19-MAR-09
JIANXIANG YUAN 209 510(k) SUMMARY AVAILABLE FROM FDA
BEI SI HUAN ZHO, BEIJING, CHINA 100083
DEVICE: EPTFE SLFTM SPIRAL VASCULAR GRAFT
TAYSIDE FLOW TECHNOLOGIES LIMITED 510(k) NO: K083169(TRADITIONAL)
ATTN: EDWIN LINDSAY PHONE NO : 004 413 82598532
1141 E. HAWKEN WAY SE DECISION MADE: 30-MAR-09
CHANDLER, AZ 85286 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C. DIFF QUIK CHEK COMPLETE
TECHLAB, INC. 510(k) NO: K082499(TRADITIONAL)
ATTN: CHARLES PENNINGTON PHONE NO : 540-953-1664
2001 KRAFT DR. SE DECISION MADE: 26-MAR-09
BLACKSBURG, VA 24060-6358 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANGEL
TEKNIMED SA 510(k) NO: K083005(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 04-MAR-09
ROUNDROCK, TX 78681 510(k) STATEMENT
DEVICE: SOMNOLYZER 24X7
THE SIESTA GROUP NORTH AMERICA 510(k) NO: K083620(TRADITIONAL)
ATTN: ZVI LADIN PHONE NO : 781-407-0900
990 WASHINGTON STREET SE DECISION MADE: 06-MAR-09
SUITE 204 510(k) SUMMARY AVAILABLE FROM FDA
DEDHAM, MA 02026
DEVICE: THEKEN ATOLL CERVICO-THORACIC SYSTEM
THEKEN SPINE LLC 510(k) NO: K083073(SPECIAL)
ATTN: DALE DAVISON PHONE NO : 330-475-8609
283 E WATERLOO RD. SE DECISION MADE: 13-MAR-09
AKRON, OH 44319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THEKEN ATOLL OCT SPINAL SYSTEM
THEKEN SPINE LLC 510(k) NO: K083863(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330-475-8600
1800 TRIPLETT BLVD. SE DECISION MADE: 27-MAR-09
AKRON, OH 44306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI VARIOMULTI ANGLED ABUTMENT
THOMMEN MEDICAL, AG 510(k) NO: K090153(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL, SE DECISION MADE: 27-MAR-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: SUPERCATH 5
TOGO MEDIKIT CO., LTD. 510(k) NO: K081953(TRADITIONAL)
ATTN: FUMIAKI KANAI PHONE NO : 813 381 88577
4-2-1 YUSHIMA, BUNKYO-KU SE DECISION MADE: 12-MAR-09
TOKYO, JAPAN 113-0034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOKUYAMA TISSUECARE
TOKUYAMA DENTAL CORPORATION 510(k) NO: K081554(TRADITIONAL)
ATTN: KEITH BARRITT PHONE NO : 202-783-5070
1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 18-MAR-09
WASHINGTON, DC 20005 510(k) STATEMENT
DEVICE: 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
TOPCON MEDICAL SYSTEMS, INC. 510(k) NO: K083316(TRADITIONAL)
ATTN: BARBARA S FANT PHONE NO : 201-961-8200
310 TERRACE AVENUE SE DECISION MADE: 13-MAR-09
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45220
DEVICE: SALTO TALARIS TOTAL ANKLE PROSTHESIS
TORNIER 510(k) NO: K090076(SPECIAL)
ATTN: SEVERINE BONNETON PHONE NO : 33 4 76613500
161 RUE LAVOISIER SE DECISION MADE: 17-MAR-09
MONTBONNOT 510(k) SUMMARY AVAILABLE FROM FDA
SAINT-ISMIER CEDEX, FRANCE 38334
DEVICE: CSBP-001A BODY PERFUSION SYSTEM
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K090504(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DRIVE SE DECISION MADE: 05-MAR-09
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781 THIRD PARTY REVIEW
DEVICE: TC ENDO PORT
TRANSCARDIAC THERAPEUTICS, INC. 510(k) NO: K083218(TRADITIONAL)
ATTN: DAVID SMITH PHONE NO : 404-816-4520
3355 LENOX RD., NE SE DECISION MADE: 06-MAR-09
SUITE 415 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30326
DEVICE: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROB
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K081063(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 06-MAR-09
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K083606(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 24-MAR-09
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: LABORPRO SYSTEM
TRIG MEDICAL LTD 510(k) NO: K081984(TRADITIONAL)
ATTN: KEREN SHTIEGMAN PHONE NO : 972 361 23281
7 JABOTINSKY STREET SE DECISION MADE: 04-MAR-09
MOSHE AVIV BUILDING 510(k) SUMMARY AVAILABLE FROM FDA
RAMAT-GAN, ISRAEL 52520
DEVICE: UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM
U.S. IMPLANT SOLUTIONS, LLC 510(k) NO: K081813(TRADITIONAL)
ATTN: SCOTT GARRETT PHONE NO : 407-971-8054
650 SOUTH CENTRAL AVENUE SE DECISION MADE: 12-MAR-09
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
OVIEDO, FL 32765
DEVICE: NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
U.S. SAFETY SYRINGES CO., INC. 510(k) NO: K090502(TRADITIONAL)
ATTN: CHRISTINA SMITH PHONE NO : 888-645-2795
1676 VILLAGE GREEN SE DECISION MADE: 10-MAR-09
CROFTON, MD 21114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
UNICARE BIOMEDICAL, INC. 510(k) NO: K090083(TRADITIONAL)
ATTN: STAN YANG PHONE NO : 949-643-6707
22971-B TRITON WAY SE DECISION MADE: 23-MAR-09
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CA
VASCULAR SOLUTIONS, INC. 510(k) NO: K083784(TRADITIONAL)
ATTN: CHARMAINE SUTTON PHONE NO : 763-656-4300
6464 SYCAMORE COURT SE DECISION MADE: 30-MAR-09
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
VERATHON INCORPORATED 510(k) NO: K090214(ABBREVIATED)
ATTN: KRISTIAN NIELSEN PHONE NO : 425-867-1348
20001 NORTH CREEK PKWY SE DECISION MADE: 13-MAR-09
BOTHEL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVENT101
VERSAMED MEDICAL SYSTEMS, INC. 510(k) NO: K081845(TRADITIONAL)
ATTN: JERRY KORTEN PHONE NO : 845-770-2840
2 BLUE HILL PLAZA SE DECISION MADE: 16-MAR-09
BLDG. 2, 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PEARL RIVER, NY 10965
DEVICE: VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE
VIRTUAL RADIOLOGIC CORPORATION 510(k) NO: K090649(TRADITIONAL)
ATTN: KIMBERLY TOKACH PHONE NO : 952-595-1100
11995 SINGLETREE LANE SE DECISION MADE: 27-MAR-09
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BODYVIZ, MODEL 100
VISUAL MEDICAL SOLUTIONS, LLC 510(k) NO: K090295(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 04-MAR-09
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITABLOCS, MODEL VX55-****
VITA ZAHNFABRIK H. RAUTER GMBH & C510(k) NO: K090644(SPECIAL)
ATTN: ELIZABETH WOLFSEN PHONE NO : 714-961-6268
3150 EAST BIRCH STREET SE DECISION MADE: 31-MAR-09
BREA, CA 92821 510(k) STATEMENT
DEVICE: GORE BIO-A FISTULA PLUG
W.L. GORE & ASSOCIATES,INC 510(k) NO: K083266(TRADITIONAL)
ATTN: BARBARA L SMITH PHONE NO : 410-506-8189
301 AIRPORT RD. SE DECISION MADE: 27-MAR-09
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONEPLANT DENTAL IMPLANT SYSTEM
WARANTEC CO., LTD. 510(k) NO: K081748(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 27-MAR-09
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
WELCH ALLYN, INC. 510(k) NO: K082478(ABBREVIATED)
ATTN: JOHN SAWYER PHONE NO : 315-685-4571
4341 STATE ST. RD. SE DECISION MADE: 09-MAR-09
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K082924(SPECIAL)
ATTN: MATT PAUL PHONE NO : 901-867-4350
5677 AIRLINE RD. SE DECISION MADE: 06-MAR-09
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURIAN TISSUE REINFORCEMENT MATRIX
XYLOS CORPORATION 510(k) NO: K083823(TRADITIONAL)
ATTN: JOYCE ELKINS PHONE NO : 215-867-0220
838 TOWN CENTER DR. SE DECISION MADE: 18-MAR-09
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDRORISE AND HYDROSYSTEM
ZHERMACK S.P.A. 510(k) NO: K083739(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 26-MAR-09
BEND, OR 97702 510(k) STATEMENT
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ZIBO GOLDENLINE PLASTIC PRODUCT CO510(k) NO: K083015(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909-548-4828
12390 EAST END AVE. SE DECISION MADE: 10-MAR-09
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCIUM FUNCTION ANALYSIS, CALCIUM SCORING
ZIOSOFT, INC. 510(k) NO: K083446(TRADITIONAL)
ATTN: RICHARD BALL PHONE NO : 650-413-1364
1000 BRIDGE PARKWAY, SUITE 100 SE DECISION MADE: 31-MAR-09
REDWOOD CITY, CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K081081(TRADITIONAL)
ATTN: EILEEN M BOYLE PHONE NO : 978-421-9171
269 MILL ROAD SE DECISION MADE: 09-MAR-09
CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 275
TOTAL WITH SUMMARIES 247
TOTAL WITH STATEMENTS 28
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