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Medical Devices
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August 2008 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-AUG-2008 THROUGH 31-AUG-2008
DEVICE: INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
MEDTRONIC INC. 510(k) NO: K073523(TRADITIONAL)
ATTN: COLLEEN MULLINS PHONE NO : 978-739-3267
37A CHERRY HILL DRIVE SE DECISION MADE: 01-AUG-08
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNIVF DISHES
GENX INTL., INC. 510(k) NO: K080395(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW RD. SE DECISION MADE: 13-AUG-08
GUILFORD, CT 06437 510(k) STATEMENT
DEVICE: RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
ABBOTT LABORATORIES 510(k) NO: K081549(TRADITIONAL)
ATTN: VIRGINIA SINGER PHONE NO : 408-845-0633
3200 LAKESIDE DRIVE SE DECISION MADE: 19-AUG-08
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
ABBOTT SPINE, INC. 510(k) NO: K081622(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 512-533-1908
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 29-AUG-08
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
ABBOTT VASCULAR-VASCULAR SOLUTIONS510(k) NO: K072708(TRADITIONAL)
ATTN: MICHELLE GROSSMAN PHONE NO : 408-845-0613
3200 LAKESIDE DR. SE DECISION MADE: 18-AUG-08
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVER ANTIMICROBIAL WOUND GEL
ADVANCED MEDICAL SOLUTIONS LIMITED510(k) NO: K073197(TRADITIONAL)
ATTN: CLAIRE RYAN PHONE NO : 44 016 06863500
ROAD THREE SE DECISION MADE: 28-AUG-08
WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD CHESHIRE, UNITED KINGDOM CW7 3PD
DEVICE: METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTE
AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K081973(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9291
3773 CORPORATE PWKY. SE DECISION MADE: 07-AUG-08
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
ALATECH HEALTHCARE, LLC. 510(k) NO: K080606(ABBREVIATED)
ATTN: NEIL ANDERSON PHONE NO : 334-688-8520
1600 STATE DOCKS RD. SE DECISION MADE: 07-AUG-08
EUFAULA, AL 36027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASS CASUALTY VENTILATOR, MODEL MCV100
ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K080063(TRADITIONAL)
ATTN: WAYNE KARCHER PHONE NO : 314-771-2400
1720 SUBLETTE AVE. SE DECISION MADE: 15-AUG-08
ST. LOUIS, MO 63110 510(k) STATEMENT
DEVICE: ALLTECH ECHOSTAR 1.5 T MR SYSTEM
ALLTECH MEDICAL SYSTEMS AMERICA, I510(k) NO: K082100(TRADITIONAL)
ATTN: JOHN DURAJ PHONE NO : 440-424-2248
30825 AURORA ROAD SE DECISION MADE: 06-AUG-08
SUITE 100 510(k) STATEMENT
SOLON, OH 44139 THIRD PARTY REVIEW
DEVICE: RFVISION, MODEL 9.9D
ALMANA MEDICAL IMAGING 510(k) NO: K080847(TRADITIONAL)
ATTN: DANIEL KAMM, P.E PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 06-AUG-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADVISION ET DIAGNOSTIC X-RAY SYSTEM
ALMANA MEDICAL IMAGING 510(k) NO: K082064(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 22-AUG-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLEX CATHETER, MODEL SL2593
ALSIUS CORP. 510(k) NO: K081936(TRADITIONAL)
ATTN: JOHN RIOLO PHONE NO : 949-453-0150
15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 13-AUG-08
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, B
AMEDICA BIOTECH, INC. 510(k) NO: K080872(SPECIAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980
28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 19-AUG-08
HAYWARD, CA 94545 510(k) STATEMENT
DEVICE: RADIANCE
AMERICAN ORTHODONTICS 510(k) NO: K080749(TRADITIONAL)
ATTN: JEROME H SCHOMBERG PHONE NO : 920-457-5051
1714 CAMBRIDGE AVE. SE DECISION MADE: 04-AUG-08
SHEBOYGAN, WI 53081 510(k) STATEMENT
DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER
ANGIOSCORE, INC. 510(k) NO: K082059(SPECIAL)
ATTN: KIMBERLEY KLINE PHONE NO : 510-933-7989
5055 BRANDIN COURT SE DECISION MADE: 11-AUG-08
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
AOTI LTD. 510(k) NO: K080966(TRADITIONAL)
ATTN: ROBBIE WALSH PHONE NO : 353 87 2355402
QUALTECH HOUSE SE DECISION MADE: 06-AUG-08
PARKMORE BUSINESS PARK WEST 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: SCANSCOPE XT SYSTEM
APERIO TECHNOLOGIES 510(k) NO: K073677(TRADITIONAL)
ATTN: JEFF RYBERG PHONE NO : 760-539-1114
1430 VANTAGE COURT, SUITE 106 SE DECISION MADE: 01-AUG-08
VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
APOLLO ENDOSURGERY, INC. 510(k) NO: K081853(TRADITIONAL)
ATTN: DENNIS MCWILLIAMS PHONE NO : 512-328-9990
7000 BEE CAVES RD. SUITE 350 SE DECISION MADE: 18-AUG-08
AUSTIN, TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APROXI 1100 AND 4000 SERIES DENTAL INLAYS
APROXI APS 510(k) NO: K073047(ABBREVIATED)
ATTN: KIRSTEN RONO PHONE NO : 45 444 84124
HOJELOFT VAENGE 206 SE DECISION MADE: 07-AUG-08
VAERLOSE, DENMARK 510(k) STATEMENT
DEVICE: ARTHROCARE ARTHROWANDS
ARTHROCARE CORP. 510(k) NO: K082323(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 28-AUG-08
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDGE PACS
ASHVA TECHNOLOGIES, PVT. LTD 510(k) NO: K081752(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 06-AUG-08
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SURGIMESH XB
ASPIDE MEDICAL 510(k) NO: K072974(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH ST. NW SE DECISION MADE: 18-AUG-08
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109
DEVICE: ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG
B. BRAUN MEDICAL, INC. 510(k) NO: K073396(TRADITIONAL)
ATTN: REBECCA STOLARICK PHONE NO : 610-596-2536
901 MARCON BLVD. SE DECISION MADE: 07-AUG-08
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
BAUSCH & LOMB, INC 510(k) NO: K082132(SPECIAL)
ATTN: NED LUCE PHONE NO : 585-338-6368
1400 NORTH GOODMAN STREET SE DECISION MADE: 28-AUG-08
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WI
BAXTER HEALTHCARE CORP. 510(k) NO: K081289(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-270-4871
1620 WAUKEGAN ROAD SE DECISION MADE: 04-AUG-08
MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRICOS A RESORBABLE SUBSTITUTE
BAXTER HEALTHCARE CORP. 510(k) NO: K081721(TRADITIONAL)
ATTN: BARBARA K BARBEAU PHONE NO : 847-270-4174
1620 WAUKEGAN ROAD SE DECISION MADE: 06-AUG-08
MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
BD BIOSCIENCES 510(k) NO: K081213(TRADITIONAL)
ATTN: NOBUKO NAKAJIMA PHONE NO : 408-954-4109
2350 QUME DR. SE DECISION MADE: 14-AUG-08
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MO
BECKMAN COULTER, INC. 510(k) NO: K080634(TRADITIONAL)
ATTN: LYNN WEIST PHONE NO : 952-368-1271
1000 LAKE HAZELTINE DR. SE DECISION MADE: 11-AUG-08
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWCARE TLG REAGENT
BECKMAN COULTER, INC. 510(k) NO: K081526(ABBREVIATED)
ATTN: NANCY NADLER PHONE NO : 305-380-4191
11800 SW 147TH AVE. SE DECISION MADE: 14-AUG-08
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KYMCO FORU, MODEL EQ35
BESTEAM TECHNOLOGY INC. 510(k) NO: K081980(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
14F-2 NO. 1 LANE 25 SE DECISION MADE: 04-AUG-08
ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: MODIFICATION TO GFX NERVE ABLATION SYSTEM
BIOFORM MEDICAL, INC. 510(k) NO: K081729(SPECIAL)
ATTN: LORI HAYS PHONE NO : 262-835-3300
4133 COURTNEY ROAD, #10 SE DECISION MADE: 07-AUG-08
FRANKSVILLE, WI 53126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
BIOGENICS, INC. 510(k) NO: K081896(TRADITIONAL)
ATTN: LOU JONES PHONE NO : 707-224-7810
2797 NAPA VALLEY CORPORATE DR. SE DECISION MADE: 20-AUG-08
NAPA, CA 94558 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: HIPLOC COMPRESSION HIP SCREW
BIOMET MANUFACTURING, INC. 510(k) NO: K080685(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 15-AUG-08
WARSAW, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEEK-OPTIMA ALIF SPACER
BIOMET SPINE 510(k) NO: K081636(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973-299-9300
100 INTERPACE PARKWAY SE DECISION MADE: 07-AUG-08
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY
BIOPLATE, INC. 510(k) NO: K082175(SPECIAL)
ATTN: JESUS T FARINAS PHONE NO : 310-815-2100
3643 LENAWEE AVE. SE DECISION MADE: 13-AUG-08
LOS ANGELES, CA 90016-4310 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPRO GO-EZ SCREW
BIOPRO, INC. 510(k) NO: K081149(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 05-AUG-08
PORT HURON, MI 48060 510(k) STATEMENT
DEVICE: STEREOS WORKSTATION
BIOSPACE MED 510(k) NO: K080529(TRADITIONAL)
ATTN: JOHN J SMITH PHONE NO : 202-637-3638
555 THIRTEENTH ST. NW SE DECISION MADE: 29-AUG-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
BLACKSTONE MEDICAL, INC. 510(k) NO: K081849(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838
1211 HAMBURG TURNPIKE SE DECISION MADE: 28-AUG-08
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WAYNE, NJ 07470
DEVICE: BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCES
BONART CO. LTD. 510(k) NO: K080761(TRADITIONAL)
ATTN: ERIC L ONG PHONE NO : 909-594-8066
398 S. LEMON CREEK DR. SE DECISION MADE: 25-AUG-08
STE. L 510(k) STATEMENT
WALNUT, CA 91789
DEVICE: BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
BONART CO. LTD. 510(k) NO: K081550(TRADITIONAL)
ATTN: ERIC L ONG PHONE NO : 909-594-8066
398 S. LEMON CREEK DR. SE DECISION MADE: 28-AUG-08
STE. L 510(k) STATEMENT
WALNUT, CA 91789
DEVICE: KINETIX GUIDEWIRE, PLUS GUIDEWIRE
BOSTON SCIENTIFIC CORP. 510(k) NO: K081021(TRADITIONAL)
ATTN: CHRISTINE THOMAS PHONE NO : 763-494-2942
ONE SCIMED PLACE A-380 SE DECISION MADE: 08-AUG-08
MAPLE GROVE, MN 55301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE PELVIC FLOOR REPAIR KIT II
BOSTON SCIENTIFIC CORP. 510(k) NO: K081048(ABBREVIATED)
ATTN: MICHELLE BARRY PHONE NO : 508-683-4941
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 22-AUG-08
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC SURGICAL MESH
BOSTON SCIENTIFIC CORP. 510(k) NO: K081275(ABBREVIATED)
ATTN: JANET A MCGRATH PHONE NO : 508-683-4921
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 27-AUG-08
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERLOC CLEAR SAFETY INFUSION SET
C.R. BARD, INC. 510(k) NO: K082306(SPECIAL)
ATTN: HENRY BOLAND PHONE NO : 801-595-0700
605 NORTH 5600 WEST SE DECISION MADE: 28-AUG-08
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
CARDIAC SCIENCE CORPORATION 510(k) NO: K082173(SPECIAL)
ATTN: BEVERLY MAGRANE PHONE NO : 425-402-2365
3303 MONTE VILLA PKWY. SE DECISION MADE: 26-AUG-08
BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES,
CARDINAL HEALTH 510(k) NO: K081464(TRADITIONAL)
ATTN: STEVE TAMSETT PHONE NO : 847-578-2325
1500 WAUKEGAN ROAD SE DECISION MADE: 28-AUG-08
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVEA VENTILATOR
CARDINAL HEALTH 207, INC. 510(k) NO: K081837(SPECIAL)
ATTN: ANDRE VON MULLER PHONE NO : 714-283-8472
22745 SAVI RANCH PARKWAY SE DECISION MADE: 13-AUG-08
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTE
CARDIO SYSTEMS, INC. 510(k) NO: K081944(SPECIAL)
ATTN: DAVID D BROOKE PHONE NO : 651-259-2061
651 CAMPUS DRIVE SE DECISION MADE: 14-AUG-08
SAINT PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MOD
CARDIOMEMS INC 510(k) NO: K082191(ABBREVIATED)
ATTN: GRACE POWERS PHONE NO : 678-651-2323
387 TECHNOLOGY CIRCLE, NW SE DECISION MADE: 19-AUG-08
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30313
DEVICE: SELF-ADHESIVE ELECTRODES
CATHAY HEALTHCARE EQUIPMENT MANUFA510(k) NO: K080276(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 562-943-4262
FLEMINGTON CT SE DECISION MADE: 04-AUG-08
SUITE 155 510(k) SUMMARY AVAILABLE FROM FDA
LA MIRADA, CA 90638
DEVICE: OHMNISCAN NG
CHRISTINE VALMY INC 510(k) NO: K073334(TRADITIONAL)
ATTN: PETER DEHAYDU PHONE NO : 973-575-1050
285, CHANGE BRIDGE ROAD SE DECISION MADE: 22-AUG-08
PINE BROOK, NJ 07058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPLATE AND COUNTER-FIT
CLINICIAN'S CHOICE DENTAL PRODUCTS510(k) NO: K081017(TRADITIONAL)
ATTN: JEANETTE SMITH PHONE NO : 519 641 3066
1980 HYDE PARK ROAD SE DECISION MADE: 04-AUG-08
LONDON, ONTARIO, CANADA N6H 5L9 510(k) STATEMENT
DEVICE: BAHA INTENSO
COCHLEAR AMERICAS 510(k) NO: K081606(TRADITIONAL)
ATTN: SEAN BUNDY PHONE NO : 800-523-5798
400 INVERNESS PARKWAY, SE DECISION MADE: 28-AUG-08
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80112
DEVICE: DERMABIOSAFE
COMPLETE PRODUCT RESOURCES 510(k) NO: K080298(TRADITIONAL)
ATTN: JOHN WALSH PHONE NO : 949-757-0460
92 ARGONAUT # 200 SE DECISION MADE: 05-AUG-08
ALISO VIEJO, CA 92656 510(k) STATEMENT
DEVICE: ATLAS-BASED AUTOSEGMENTATION
COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K080799(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314-993-0003
1145 CORPORATE LAKE DR. SE DECISION MADE: 07-AUG-08
ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MERCI RETRIEVER
CONCENTRIC MEDICAL, INC. 510(k) NO: K082034(SPECIAL)
ATTN: LARAINE PANGELINA PHONE NO : 650-938-2100
301 E. EVELYN AVE. SE DECISION MADE: 15-AUG-08
MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APPROACH CTO WIRE GUIDE
COOK INCORPORATED 510(k) NO: K081337(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235
750 DANIELS WAY, P.O. BOX 489 SE DECISION MADE: 08-AUG-08
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ZILVER 635 BILIARY STENT
COOK, INC. 510(k) NO: K080037(TRADITIONAL)
ATTN: STEPHANIE ROBERTS PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 01-AUG-08
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAFLEX HIGH FLOW MICROCATHETER
COOK, INC. 510(k) NO: K080737(SPECIAL)
ATTN: NATHAN SIMON PHONE NO : 800-346-2686
750 DANIELS WAY PO BX 489 SE DECISION MADE: 08-AUG-08
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO GUIDE CATHETER XP
CORDIS CORP. 510(k) NO: K082143(SPECIAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257
7 POWDER HORN DR. SE DECISION MADE: 25-AUG-08
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE
CRAFTMASTER CONTOUR EQUIPMENT, INC510(k) NO: K081237(TRADITIONAL)
ATTN: STUART R GOLDMAN PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 25-AUG-08
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: CURBELL PATIENT MONITORING CABLES
CURBELL ELECTRONICS INC. 510(k) NO: K081762(ABBREVIATED)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
5401 S. COTTONWOOD CT. SE DECISION MADE: 27-AUG-08
GREENWOOD VILLAGE, CO 80121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
CUTERA, INC. 510(k) NO: K080530(SPECIAL)
ATTN: KATHY MAYNOR PHONE NO : 415-657-5586
3240 BAYSHORE BLVD SE DECISION MADE: 15-AUG-08
BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYGNUS 12 LEAD ECG MODULE
CYGNUS, LLC 510(k) NO: K072950(TRADITIONAL)
ATTN: NARCIS NAYDENOV PHONE NO : 973-523-0668
510 EAST 41ST ST. SE DECISION MADE: 22-AUG-08
PATERSON, NJ 07504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DATEX-OHMEDA AVANCE
DATEX-OHMEDA, INC. 510(k) NO: K081844(SPECIAL)
ATTN: ADRIENNE LENZ PHONE NO : 608-221-1551
PO BOX 7550 SE DECISION MADE: 29-AUG-08
3030 OHMEDA DR. 510(k) SUMMARY AVAILABLE FROM FDA
MADISON, WI 53707
DEVICE: DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K080990(TRADITIONAL)
ATTN: DAWN SINCLAIR PHONE NO : 574-372-5023
700 ORTHOPAEDIC DR. SE DECISION MADE: 08-AUG-08
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL BONE LOCKING PLATING SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K081546(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-6386
700 ORTHOPAEDIC DR. SE DECISION MADE: 26-AUG-08
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY C-STEM AMT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K082239(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 29-AUG-08
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALOS II BONE GRAFT SUBSTITUTE
DEPUY SPINE, INC. 510(k) NO: K081432(TRADITIONAL)
ATTN: HANDE TUFAN PHONE NO : 508-828-3065
325 PARAMOUNT DR. SE DECISION MADE: 29-AUG-08
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDILAS D FAMILY LASERS
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K073427(TRADITIONAL)
ATTN: THERON GOBER PHONE NO : 770-514-6204
1155 ROBERTS BLVD. SE DECISION MADE: 20-AUG-08
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XERACEM
DOXA DENTAL AB 510(k) NO: K081405(ABBREVIATED)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET NW SE DECISION MADE: 21-AUG-08
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: PICASSO MASTER, ECT AND MASTER 3D
E-WOO TECHNOLOGY 510(k) NO: K081847(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 281-598-8124
256 NORTH SAM HOUSTON PKWY E. SE DECISION MADE: 21-AUG-08
SUITE 115 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77060 THIRD PARTY REVIEW
DEVICE: ANYRAY PORTABLE X-RAY SYSTEM
E-WOO TECHNOLOGY CO., LTD. 510(k) NO: K081899(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 281-598-8124
256 NORTH SAM HOUSTON PKWY E. SE DECISION MADE: 21-AUG-08
#115 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77060 THIRD PARTY REVIEW
DEVICE: DSA 2000EX
EIGEN LLC 510(k) NO: K082341(TRADITIONAL)
ATTN: ANIMESH KHEMKA PHONE NO : 530-274-1240
13366 GRASS VALLEY AVE. SE DECISION MADE: 29-AUG-08
GRASS VALLEY, CA 95945 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MLCI2
ELEKTA LTD. 510(k) NO: K082122(SPECIAL)
ATTN: PATRICK T HULL PHONE NO : 441 293 544422
LINAC HOUSE SE DECISION MADE: 29-AUG-08
FLEMING WAY, CRAWLEY 510(k) SUMMARY AVAILABLE FROM FDA
WEST SUSSEX, UNITED KINGDOM RH10 9RR
DEVICE: CLAROS NANO DENTAL LASER SYSTEM
ELEXXION AG 510(k) NO: K081652(ABBREVIATED)
ATTN: HOLGER ERNST PHONE NO : 497 732 822990
SCHUETZENSTR. 84 SE DECISION MADE: 28-AUG-08
RADOLFZELL, GERMANY 78315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBLETTA GOLD
EMBLA SYSTEMS, INC. 510(k) NO: K073682(TRADITIONAL)
ATTN: ROBERT G SCHUEPPERT PHONE NO : 303-962-1786
11001 W. 120TH AVE. SE DECISION MADE: 08-AUG-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
BROOMFIELD, CO 80021
DEVICE: REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MO
ENCORE MEDICAL, L.P. 510(k) NO: K081679(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 20-AUG-08
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE T
ESCADA INTERNATIONAL, INC. 510(k) NO: K080102(SPECIAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 20-AUG-08
LITTLETON, CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTREMITY MEDICAL COMPRESSION SCREW
EXTREMITY MEDICAL LLC 510(k) NO: K081934(TRADITIONAL)
ATTN: JAMY GANNOE PHONE NO : 973-316-9900
300 INTERPACE PARKWAY SE DECISION MADE: 29-AUG-08
SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA
PARSIPPANY, NJ 07054
DEVICE: DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL P
FEG TEXTILTECHNIK FORSCHUNGS-UND E510(k) NO: K073579(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 011 441 763222505
BUSINESS & TECHNOLOGY CENTER/ SE DECISION MADE: 18-AUG-08
BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
STEVENAGE, UNITED KINGDOM SG1 2DX
DEVICE: FIATLUX VISUALIZE
FIATLUX IMAGING INC. 510(k) NO: K082041(TRADITIONAL)
ATTN: PHONE NO :
8430 154TH AVE. NE SE DECISION MADE: 01-AUG-08
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
FOCUS DIAGNOSTICS, INC. 510(k) NO: K073381(TRADITIONAL)
ATTN: CONSTANCE BRIDGES PHONE NO : 714-503-2007
10703 PROGRESS WAY SE DECISION MADE: 04-AUG-08
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOSSA URETERAL OPEN STENTS
FOSSA MEDICAL, INC. 510(k) NO: K072293(TRADITIONAL)
ATTN: GLORIA KOLB PHONE NO : 781-455-6704
50 REDFIELD STREET SE DECISION MADE: 06-AUG-08
BOSTON, MA 02122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
FUJIREBIO DIAGNOSTICS TEXAS, INC. 510(k) NO: K080273(TRADITIONAL)
ATTN: JOHN GORMLEY PHONE NO : 830-372-1301
940 CROSSROADS BLVD. SE DECISION MADE: 08-AUG-08
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDTX GLUCOSE CONTROL SOLUTION
FUJIREBIO DIAGNOSTICS TEXAS, INC. 510(k) NO: K081915(TRADITIONAL)
ATTN: JOHN GORMLEY PHONE NO : 830-372-1391
940 CROSSROADS BLVD. SE DECISION MADE: 08-AUG-08
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR
FUKUDA DENSHI USA, INC. 510(k) NO: K081891(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 29-AUG-08
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
G & H WIRE CO. 510(k) NO: K081393(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 NORTH MERIDIAN STREET SE DECISION MADE: 21-AUG-08
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032
DEVICE: CENTRICITY PACS IW
GE HEALTHCARE DYNAMIC IMAGING SOLU510(k) NO: K082318(SPECIAL)
ATTN: JILLIAN M REED PHONE NO : 203-459-0659
25 WALNUT ST. SE DECISION MADE: 25-AUG-08
MONROE, CT 06468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATOR APPLICATIONS SUITE
GE HEALTHCARE FINLAND OY 510(k) NO: K081941(SPECIAL)
ATTN: ADRIENNE LENZ PHONE NO : 608-221-1551
3030 OHMEDA DRIVE SE DECISION MADE: 07-AUG-08
PO BOX 7550 510(k) SUMMARY AVAILABLE FROM FDA
MADISON, WI 53707-7550
DEVICE: GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 520500
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K082185(SPECIAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 414-721-2272
9900 INNOVATION DR. SE DECISION MADE: 15-AUG-08
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VIVID E9 ULTRASOUND
GENERAL ELECTRIC CO. 510(k) NO: K081921(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
9900 INNOVATION DRIVE SE DECISION MADE: 06-AUG-08
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTIAN CYSTATIN C IMMUNOASSAY
GENTIAN AS 510(k) NO: K081875(SPECIAL)
ATTN: ERIC S GRUFF PHONE NO : 858-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 20-AUG-08
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4
GLOBAL TOP, INC. 510(k) NO: K081200(TRADITIONAL)
ATTN: CLAUDE YANG PHONE NO : 082 256 63360
#708 LE-MEILLEUR TOWN, 837-19 SE DECISION MADE: 08-AUG-08
GANGNAM-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 135-937
DEVICE: LASERPEEL SOFT-MET MODIFIED ERBIUM LASER
GLOBAL USA DISTRIBUTION, LLC. 510(k) NO: K082028(TRADITIONAL)
ATTN: MATT MAKOUSKY PHONE NO : 612-237-6928
10723 AQUILA AV. S. SE DECISION MADE: 08-AUG-08
MINNEAPOLIS, MN 55438 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMO
GX CORPORATION SDN BHD 510(k) NO: K081315(TRADITIONAL)
ATTN: FOO K PU PHONE NO : 603 329 11600
LOT 6487, BATU 5 3/4, SEMENTA SE DECISION MADE: 11-AUG-08
JALAN KAPAR 510(k) STATEMENT
KLANG, MALAYSIA 42100
DEVICE: GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AN
GYRUS ACMI, INC. 510(k) NO: K082054(SPECIAL)
ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2600
136 TURNPIKE RD. SE DECISION MADE: 06-AUG-08
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PKS OMNI INSTRUMENT
GYRUS-ACMI L.P. 510(k) NO: K081766(TRADITIONAL)
ATTN: LORRAINE CALZETTA PHONE NO : 508-804-2752
136 TURNPIKE RD. SE DECISION MADE: 08-AUG-08
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
HANSEN MEDICAL, INC. 510(k) NO: K082075(SPECIAL)
ATTN: KATE WHITIN PHONE NO : 650-404-5841
800 E. MIDDLEFIELD ROAD SE DECISION MADE: 15-AUG-08
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/
HARVARD MEDICAL DEVICES LTD. 510(k) NO: K081159(TRADITIONAL)
ATTN: PAUL AYLETT PHONE NO : 852 273 52161
39 CHATHAM ROAD SOUTH SE DECISION MADE: 08-AUG-08
TSIMSHATSUI, KOWLOON, HONG KONG 510(k) STATEMENT
DEVICE: MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K072486(TRADITIONAL)
ATTN: KEVIN HAWKINS PHONE NO : 503-245-0459
10575 SW CASCADE AVENUE SE DECISION MADE: 06-AUG-08
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
PORTLAND, OR 97223-4363
DEVICE: ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K081745(TRADITIONAL)
ATTN: DOUG THISTLEWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 12-AUG-08
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
HOME DIAGNOSTICS, INC. 510(k) NO: K080641(TRADITIONAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 19-AUG-08
FORT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
HOME DIAGNOSTICS, INC. 510(k) NO: K080710(TRADITIONAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 13-AUG-08
FORT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: SCULPTURE 2.94 ER:YAG SYSTEM
HOYA CONBIO, INC 510(k) NO: K073158(TRADITIONAL)
ATTN: LIZA BURNS PHONE NO : 209-586-0416
19722 WESTVIEW DRIVE SE DECISION MADE: 27-AUG-08
TWAIN HARTE, CA 95383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
HSINER CO., LTD. 510(k) NO: K082009(SPECIAL)
ATTN: TOM SHANKS PHONE NO : 951-506-2674
29201 VIA NORTE SE DECISION MADE: 22-AUG-08
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODY-JET
HUMAN MED AG 510(k) NO: K082025(TRADITIONAL)
ATTN: INGE MATTHIESEN PHONE NO : 49 385 395700
WILHELM-HENNEMANN-STR.9 SE DECISION MADE: 13-AUG-08
SCHWERIN, GERMANY 19061 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM,
ICU MEDICAL INC 510(k) NO: K081361(TRADITIONAL)
ATTN: TRACY BEST PHONE NO : 801-264-1332
4455 ATHERTON DRIVE SE DECISION MADE: 28-AUG-08
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INAREX, MODEL 2D-LX
INAREX CORPORATION 510(k) NO: K080554(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 562-943-4262
FLEMINGTON CT. # 155 SE DECISION MADE: 27-AUG-08
LA MIRADA, CA 90638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
INJECTIMED, INC. 510(k) NO: K073664(TRADITIONAL)
ATTN: RICHARD G HUNTER PHONE NO : 770-851-1827
5616 MARIOLA PL NE SE DECISION MADE: 08-AUG-08
ALBUQUERQUE, NM 87111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IEC MEDSIGHT AND MEDBRIGHT
INNOVATIVE ENDOSCOPY COMPONENTS, L510(k) NO: K080809(TRADITIONAL)
ATTN: GERALD GOIFITZER PHONE NO : 954-217-8780
731-733 SHOTGUN RD. SE DECISION MADE: 11-AUG-08
FT. LAUDERDALE, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOMAX DS (DELIVERY SYSTEM), MODEL 10003
INO THERAPEUTICS 510(k) NO: K080484(SPECIAL)
ATTN: DAVID TRUEBLOOD PHONE NO : 608-395-3910
6 ROUTE 173 SE DECISION MADE: 06-AUG-08
CLINTON, NJ 08809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOMAX DS (DELIVERY SYSTEM)
INO THERAPEUTICS LLC 510(k) NO: K081691(SPECIAL)
ATTN: DAVID TRUEBLOOD PHONE NO : 608-395-3910
2820 WALTON COMMONS WEST SE DECISION MADE: 28-AUG-08
MADISON, WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTRUMED RONGEUR
INSTRUMED INTERNATIONAL, INC. 510(k) NO: K081651(TRADITIONAL)
ATTN: MICHAEL MASSONG PHONE NO : 847-908-0292
626 COOPER COURT SE DECISION MADE: 08-AUG-08
SCHAUMBURG, IL 60173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
INTEGRA RADIONICS, INC. 510(k) NO: K081459(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-565-1227
22 TERRY AVENUE SE DECISION MADE: 13-AUG-08
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGIMATCH ROBODOC SURGICAL SYSTEM
INTEGRATED SURGICAL SYSTEMS, INC. 510(k) NO: K072629(TRADITIONAL)
ATTN: RUSS HIBBERT PHONE NO : 916-285-9943
1433 N. MARKET BLVD., #1 SE DECISION MADE: 06-AUG-08
SACREMENTO, CA 95834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
INTUITIVE SURGICAL, INC. 510(k) NO: K073112(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 01-AUG-08
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAMILI OF IRIDEX IQ LASER SYSTEMS
IRIDEX CORP. 510(k) NO: K071687(TRADITIONAL)
ATTN: DAVID BUZAWA PHONE NO : 650-962-8848
1212 TERRA BELLA AVE. SE DECISION MADE: 07-AUG-08
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
IRVINE BIOMEDICAL, INC. 510(k) NO: K082061(SPECIAL)
ATTN: JEANETTE HENDRICKSON PHONE NO : 949-769-5006
2375 MORSE AVE. SE DECISION MADE: 19-AUG-08
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATCH-PAT 200S-2 (WP200S-2)
ITAMAR MEDICAL 510(k) NO: K081982(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 14-AUG-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TM-400
ITO CO., LTD. 510(k) NO: K081247(TRADITIONAL)
ATTN: KENNETH L BLOCK PHONE NO : 972-480-9554
1201 RICHARDSON DR., SUITE 140 SE DECISION MADE: 25-AUG-08
RICHARDSON, TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)
JIANGSU CUREGUARD GLOVE CO., LTD. 510(k) NO: K081657(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441
ROOM 1606 BLDG. 1 JIANX. YUAN SE DECISION MADE: 20-AUG-08
NO. 209 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA
HAIDIAN DISTRICT, BEIJING, CHINA 100083
DEVICE: HAIDA MODEL HD11 MANUAL WHEELCHAIR
JIANGYIN EAST CHINA MEDICAL TECHNO510(k) NO: K082274(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396
14F-2, NO. 1, ZHUANGJING RD. SE DECISION MADE: 19-AUG-08
LANE 25 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: HAIDA HD21
JIANGYIN EAST CHINA MEDICAL TECHNO510(k) NO: K082288(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
14F-2, NO. 1, ZHUANGJING RD. SE DECISION MADE: 19-AUG-08
LANE 25 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: JMEA CANNULATED BONE SCREW SYSTEM
JMEA CORPORATION 510(k) NO: K080259(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-746-9583
1 RESEARCH COURT SE DECISION MADE: 20-AUG-08
SUITE 450 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850
DEVICE: ORTHO ALL-FLEX DIAPHRAGM
JOHNSON & JOHNSON PRODUTOS PROFISS510(k) NO: K080040(TRADITIONAL)
ATTN: WILLIAM GREENROSE PHONE NO : 603-369-3550
220 RIVER ROAD SE DECISION MADE: 25-AUG-08
CLAREMONT, NH 03743-5647 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DMC COMPOSITE
KERR CORP. 510(k) NO: K081695(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714-516-7602
1717 W. COLLINS AVENUE SE DECISION MADE: 12-AUG-08
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KETTOSIL AND SILGINAT
KETTENBACH GMBH & CO KG 510(k) NO: K082157(TRADITIONAL)
ATTN: MICHAELA ZINKE PHONE NO : 49 277 470558
IM HEERFELD 7 SE DECISION MADE: 06-AUG-08
ESCHENBURG, GERMANY 35713 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VOLUMINA
KJAYA MEDICAL, LLC 510(k) NO: K081215(TRADITIONAL)
ATTN: KOVALAN MUNIANDY PHONE NO : 203-653-3496
263 TRESSER BLVD., 9TH FLOOR SE DECISION MADE: 26-AUG-08
STAMFORD, CT 06901 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TAXI ENDOSCOPIC GUIDEWIRE
LAKE REGION MFG., INC. 510(k) NO: K081708(TRADITIONAL)
ATTN: DEEP PAL PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 26-AUG-08
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
LAURIMED LLC 510(k) NO: K082194(TRADITIONAL)
ATTN: NANCY LINCE PHONE NO : 650-587-5296
500 ARGUELLO STREET, SUITE 100 SE DECISION MADE: 28-AUG-08
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSC LIPID CONTROL
MAINE STANDARDS CO. 510(k) NO: K082067(TRADITIONAL)
ATTN: HOLLY CRESSMAN PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 22-AUG-08
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAX ADJUSTING INSTRUMENT
MANNA OMNI INTERNATIONAL INC. 510(k) NO: K082218(TRADITIONAL)
ATTN: STEPHEN TSAI PHONE NO : 714-871-7118
340 E. COMMONWEALTH AVE. SE DECISION MADE: 13-AUG-08
FULLERTON, CA 92832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-INSIGHT
MAZOR SURGICAL TECHNOLOGIES LTD. 510(k) NO: K081672(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
20 HATA'AS ST. SE DECISION MADE: 15-AUG-08
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MESACUP MODELS BP180 AND BP230 ELISA KITS
MBL INTERNATIONAL CORPORATION 510(k) NO: K071961(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 25-AUG-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNASSIGNED
MEDCOMP 510(k) NO: K080544(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 14-AUG-08
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRILAZE LASER ABLATION SYSTEM
MEDICALCV, INC. 510(k) NO: K081457(TRADITIONAL)
ATTN: KIRK S HONOUR PHONE NO : 651-452-3000
9725 SOUTH ROBERT TRAIL SE DECISION MADE: 08-AUG-08
INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS
MEDISISS 510(k) NO: K081559(TRADITIONAL)
ATTN: BRANDI JAMES PHONE NO : 541-923-3310
2747 SW 6TH STREET SE DECISION MADE: 28-AUG-08
REDMOND, OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCTIC BLAST INTRAVENOUS FLUID CHILLER
MEDIVANCE, INC. 510(k) NO: K080899(TRADITIONAL)
ATTN: LYNNE ARONSON PHONE NO : 303-926-1917
1172 CENTURY DR., SUITE 240 SE DECISION MADE: 07-AUG-08
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
MEDSOURCE INTERNATIONAL, LLC. 510(k) NO: K081516(TRADITIONAL)
ATTN: PHONE NO :
5346 SHORELINE DR. SE DECISION MADE: 26-AUG-08
MOUND, MN 55364 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PIONEER PLUS CATHETER
MEDTRONIC INC. 510(k) NO: K081804(TRADITIONAL)
ATTN: CATHERINE PRIESTLEY PHONE NO : 707-591-7205
3576 UNOCAL PLACE SE DECISION MADE: 05-AUG-08
SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 4
MEDTRONIC NEUROSURGERY 510(k) NO: K082127(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-571-8445
125 CREMONA DR. SE DECISION MADE: 27-AUG-08
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K081038(TRADITIONAL)
ATTN: CHRIS MCKEE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 15-AUG-08
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 XVBR SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K082112(SPECIAL)
ATTN: MELISA LANSKY PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 27-AUG-08
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESCUE EXTERNAL IMPLANT SYSTEM
MEGAGEN IMPLANT CO., LTD 510(k) NO: K081302(TRADITIONAL)
ATTN: JUNG B BANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 15-AUG-08
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: EZ REGULAR
MEINNTECH CO., LTD. 510(k) NO: K080303(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 05-AUG-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIUM DETACHABLE COIL SYSTEM
MICRO THERAPEUTICS, INC. 510(k) NO: K081465(TRADITIONAL)
ATTN: NEELU MEDHEKAR PHONE NO : 949-837-3700
9775 TOLEDO WAY SE DECISION MADE: 19-AUG-08
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS ASCENT OCCLUSION BALLOON CATHETER
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K080861(TRADITIONAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1428
821 FOX LANE SE DECISION MADE: 27-AUG-08
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINSENSE POLYISOPRENE UNDERGLOVE
MOLNLYCKE HEALTH CARE US, LLC 510(k) NO: K081180(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-250-7930
5550 PEACHTREE PARKWAY SE DECISION MADE: 26-AUG-08
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: SYGNAL DBM
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K080405(TRADITIONAL)
ATTN: NANCY BENNEWITZ JOY PHONE NO : 732-661-2381
125 MAY ST, STE 300 SE DECISION MADE: 28-AUG-08
EDISON CORP CTR 510(k) SUMMARY AVAILABLE FROM FDA
EDISON, NJ 08837
DEVICE: PAINSHIELD MD
NANO VIBRONIX LTD. 510(k) NO: K081075(TRADITIONAL)
ATTN: ELI ORBACH PHONE NO : 972 299 32768
POB 6718 SE DECISION MADE: 22-AUG-08
EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
NIHON KOHDEN AMERICA, INC. 510(k) NO: K080546(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 29-AUG-08
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORAS MR-BI320-PA 3T
NORAS MRI PRODUCTS GMBH 510(k) NO: K082373(ABBREVIATED)
ATTN: PATRICIA KRAPF PHONE NO : 49 931 2992719
LEIBNITZSTRASSE 4 SE DECISION MADE: 29-AUG-08
HOECHBERG, GERMANY 97204 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TCM ENDO 20
NOUVAG AG 510(k) NO: K081191(TRADITIONAL)
ATTN: ERICH FORSTER PHONE NO : 041 56 2019500
REUSSWEHRSTRASSE 1 SE DECISION MADE: 07-AUG-08
GEBENSTORF, SWITZERLAND CH-5412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATIO
OMNIGUIDE, INC. 510(k) NO: K081939(TRADITIONAL)
ATTN: DOUGLAS W WOODRUFF PHONE NO : 617-551-8404
ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 12-AUG-08
3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139 THIRD PARTY REVIEW
DEVICE: VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCT
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K082099(SPECIAL)
ATTN: MARLENE A HANNA PHONE NO : 585-453-404
100 INDIGO CREEK DR. SE DECISION MADE: 21-AUG-08
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTA COLLAGEN BIOMATERIAL
OSSEOUS TECHNOLOGIES OF AMERICA 510(k) NO: K073685(TRADITIONAL)
ATTN: DAVID J COLLETTE PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 29-AUG-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COA
OSTEOMED L.P. 510(k) NO: K081876(SPECIAL)
ATTN: ALMA RELJA PHONE NO : 972-677-4781
3885 ARAPAHO RD. SE DECISION MADE: 01-AUG-08
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K082186(SPECIAL)
ATTN: BRIAN CLEARY PHONE NO : 425-636-4079
10801 120TH AVENUE NE SE DECISION MADE: 29-AUG-08
KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUTE-IT II VENEER CEMENT, MODEL NO6
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K081887(TRADITIONAL)
ATTN: GREG MOREAU PHONE NO : 203-265-7397
68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 29-AUG-08
ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: PERIMETRICS PERIOMETER
PERIMETRICS, INC. 510(k) NO: K072213(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
27001 LA PAZ, SUITE 314 SE DECISION MADE: 29-AUG-08
MISSION VIEJO, CA 92691 510(k) STATEMENT
DEVICE: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
PHILIPS MEDICAL SYSTEMS 510(k) NO: K081983(SPECIAL)
ATTN: CLAIRE ARAKAKI PHONE NO : 978-659-4348
3000 MINUTEMEN RD. SE DECISION MADE: 22-AUG-08
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULE
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K081937(SPECIAL)
ATTN: JENS-PETER SEHER PHONE NO : 49 703 14632086
HEWLETT-PACKARD STR.2 SE DECISION MADE: 29-AUG-08
BOEBLINGEN, GERMANY D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K081558(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 25-AUG-08
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLANMECA SOVEREIGN
PLANMECA USA, INC. 510(k) NO: K081699(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-529-2300
100 N. GARY AVE. SUITE A SE DECISION MADE: 29-AUG-08
ROSELLE, IL 60172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
PRAXIM 510(k) NO: K081232(TRADITIONAL)
ATTN: ANNIE POLLIER PHONE NO : 33 4 76549503
LE GRAND SABLON SE DECISION MADE: 06-AUG-08
4 AVENUE DE L'OBIOU 510(k) SUMMARY AVAILABLE FROM FDA
LA TRONCHE, FRANCE 38700
DEVICE: MAPERSOL
PRESERVATION SOLUTIONS, INC. 510(k) NO: K080432(TRADITIONAL)
ATTN: NEIL BURRIS PHONE NO : 720-323-1662
4250 GROVE STREET SE DECISION MADE: 08-AUG-08
DENVER, CO 80211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE M
PRIMED MEDICAL PRODUCTS INC. 510(k) NO: K081633(SPECIAL)
ATTN: RAYMOND G MARUSYK PHONE NO : 780 497 7600
SUITE 900, 10707-100 AVE. SE DECISION MADE: 11-AUG-08
EDMONTON, ALBERTA, CANADA T5J 3M1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
PRONIA MEDICAL SYSTEM, LLC 510(k) NO: K081388(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 21-AUG-08
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
PT. MAJA AGUNG LATEXINDO 510(k) NO: K081488(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIELS ST. SE DECISION MADE: 28-AUG-08
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AP 34 MULTI-THERAPY INFUSION PUMP
Q-CORE, LTD 510(k) NO: K082182(TRADITIONAL)
ATTN: ASHER KASSEL PHONE NO : 972 732 388888
PO BOX 3341 SE DECISION MADE: 15-AUG-08
14 HAMEFALSIM ST. KIRYAT ARYEH 510(k) SUMMARY AVAILABLE FROM FDA
PETACH TIKVA, ISRAEL 49130 THIRD PARTY REVIEW
DEVICE: REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C
REACH SURGICAL, INC 510(k) NO: K071023(TRADITIONAL)
ATTN: RICH GRANT PHONE NO : 513-769-1916
4480 LAKE FOREST DR. SE DECISION MADE: 28-AUG-08
SUITE 414 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45242
DEVICE: OCULAR RESPONSE ANALYZER
REICHERT INC. 510(k) NO: K081756(TRADITIONAL)
ATTN: SANDRA BROWN PHONE NO : 718-686-4599
3362 WALDEN AVE. SE DECISION MADE: 07-AUG-08
DEPEW, NY 14043 510(k) STATEMENT
DEVICE: RHYTEC, INC., PORTRAIT PSR
RHYTEC INCORPORATED 510(k) NO: K082197(SPECIAL)
ATTN: ROBERT ZOLETTI PHONE NO : 781-419-9482
130 TURNER STREET SE DECISION MADE: 22-AUG-08
BUILDING 2 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02453
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
RICH MOUNTAIN MEDICAL PRODUCTS, IN510(k) NO: K081535(ABBREVIATED)
ATTN: MICHELLE SHIH PHONE NO : 011 886 266003631
NO. 8, JIANG YIN ROAD SE DECISION MADE: 14-AUG-08
YI TANG TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
PIZHOU, JIANGSU, CHINA
DEVICE: ELECSYS ANTI-TSHR CALCHECK
ROCHE DIAGNOSTICS 510(k) NO: K080643(TRADITIONAL)
ATTN: STEPHANIE GREEMAN PHONE NO : 317-521-2458
9115 HAGUE RD. SE DECISION MADE: 22-AUG-08
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARRIAZO-PENDULAR MICROKERATOME
SCHWIND EYE-TECH-SOLUTIONS GMBH & 510(k) NO: K082043(TRADITIONAL)
ATTN: ROLF SCHWIND PHONE NO : 49 602 75080
MAINPARKSTRASSE 6-10 SE DECISION MADE: 01-AUG-08
KLEINOSTHEIM, GERMANY 63801 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR,
SENORX, INC. 510(k) NO: K081085(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-362-4800
11 COLUMBIA SE DECISION MADE: 01-AUG-08
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINDRWIRZ GUIDE WIRE SYSTEM
SENTREHEART INC. 510(k) NO: K080364(TRADITIONAL)
ATTN: LINDA GUTHRIE PHONE NO : 650-354-1200
2468 EMBARCADERO WAY SE DECISION MADE: 11-AUG-08
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN
SHENYANG CANTA MEDICAL TECH CO., L510(k) NO: K081508(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467
SUITE 8D, NO. 19, LANE 999 SE DECISION MADE: 27-AUG-08
ZHONGSHAN NO.2 ROAD (S) 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
SICEL TECHNOLOGIES, INC. 510(k) NO: K081859(SPECIAL)
ATTN: SUZANNE SCHWALLER PHONE NO : 919-465-2236
3800 GATEWAY CENTRE BLVD. SE DECISION MADE: 04-AUG-08
SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL
SIEMENS 510(k) NO: K081182(TRADITIONAL)
ATTN: LIBBY WARRINER PHONE NO : 916-374-3244
1584 ENTERPRISE BLVD. SE DECISION MADE: 08-AUG-08
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K080167(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914-524-2443
511 BENEDICT AVENUE SE DECISION MADE: 08-AUG-08
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K081731(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
SE DECISION MADE: 29-AUG-08
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VIS
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081299(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
500 GBC DRIVE SE DECISION MADE: 08-AUG-08
MS 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19702
DEVICE: DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC5
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081319(ABBREVIATED)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
500 GBC DRIVE SE DECISION MADE: 04-AUG-08
MS 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19702
DEVICE: DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081992(SPECIAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
PO BOX 6101 SE DECISION MADE: 05-AUG-08
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K082030(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
PO BOX 6101 SE DECISION MADE: 22-AUG-08
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YSIO
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K081722(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1787
51 VALLEY STREAM PKWY. SE DECISION MADE: 22-AUG-08
MS E-50 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: XIOS PLUS WALL-MODULE
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K081903(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO : 49 625 1163294
FABRIKSTRASSE 31 SE DECISION MADE: 26-AUG-08
BENSHEIM, GERMANY D-64625 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
SMITH & NEPHEW, INC. 510(k) NO: K081511(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
150 MINUTEMAN RD. SE DECISION MADE: 26-AUG-08
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
SMITH & NEPHEW, INC. 510(k) NO: K081566(SPECIAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520
1450 E BROOKS ROAD SE DECISION MADE: 21-AUG-08
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SI
SMITHS MEDICAL ASD, INC. 510(k) NO: K081086(TRADITIONAL)
ATTN: JOHN TULLETT PHONE NO : 44 130 3260551
MILITARY ROAD SE DECISION MADE: 13-AUG-08
HYTHE, KENT, UNITED KINGDOM CT216J510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIETEX COMPOSITE MONO PM MESH
SOFRADIM PRODUCTION 510(k) NO: K081126(TRADITIONAL)
ATTN: SHARON ALEXANDER PHONE NO : 203-492-6060
60 MIDDLETOWN AVENUE SE DECISION MADE: 13-AUG-08
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOSITE MAXX SERIES ULTRASOUND SYSTEM
SONOSITE,INC. 510(k) NO: K082098(TRADITIONAL)
ATTN: CHRISTOPHER J HARTZOG PHONE NO : 425-951-1419
21919 30TH DRIVE SE. SE DECISION MADE: 25-AUG-08
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
SPACELABS MEDICAL INC. 510(k) NO: K082045(SPECIAL)
ATTN: TIM DAVIS PHONE NO : 812-614-5072
2235 EAST FLAMINGO RD. SE DECISION MADE: 01-AUG-08
SUITE 201G 510(k) SUMMARY AVAILABLE FROM FDA
LAS VEGAS, NV 89119
DEVICE: MODIFICATION TO LUCENT
SPINAL ELEMENTS, INC. 510(k) NO: K081968(SPECIAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 05-AUG-08
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE
SPINE VIEW, INC. 510(k) NO: K081051(TRADITIONAL)
ATTN: ROY CHIN PHONE NO : 510-377-0898
48541 WARM SPRINGS BLVD. SE DECISION MADE: 07-AUG-08
SUITE 507 510(k) SUMMARY AVAILABLE FROM FDA
FREMONT, CA 94539
DEVICE: SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL D
ST. JUDE MEDICAL 510(k) NO: K081365(TRADITIONAL)
ATTN: ELIZABETH E NEELY PHONE NO : 408-522-6494
701 EAST EVELYN AVENUE SE DECISION MADE: 15-AUG-08
SUNNYVALE, CA 94086-6527 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROLL-X GUIDEWIRE
ST. JUDE MEDICAL 510(k) NO: K082304(TRADITIONAL)
ATTN: JEFF STURM PHONE NO : 763-383-2640
14901 DEVEAU PL. SE DECISION MADE: 27-AUG-08
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
STEREOTAXIS, INC. 510(k) NO: K080637(TRADITIONAL)
ATTN: DENNIS POZZO PHONE NO : 341-678-6136
4320 FOREST PARK AVENUE SE DECISION MADE: 12-AUG-08
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ST. LOUIS, MO 63108
DEVICE: REPROCESSED EXTERNAL FIXATION ACCESSORIES
STERILMED, INC. 510(k) NO: K081342(TRADITIONAL)
ATTN: JOSHUA CLARIN PHONE NO : 763-488-3483
11400 73RD AVE. NORTH SE DECISION MADE: 13-AUG-08
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED EXTERNAL FIXATION DEVICE
STERILMED, INC. 510(k) NO: K081586(TRADITIONAL)
ATTN: JOSHUA CLARIN PHONE NO : 612-644-8402
11140 73RD AVE. NORTH SE DECISION MADE: 18-AUG-08
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIS RESERT XL TEST STRIP
STERIS CORPORATION 510(k) NO: K081600(TRADITIONAL)
ATTN: JOHN SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 22-AUG-08
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 10
STERITEC PRODUCTS, INC. 510(k) NO: K080136(TRADITIONAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY, SUITE 400 SE DECISION MADE: 15-AUG-08
CASTLE ROCK, CO 80109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER ESSX MICRODEBRIDER SYSTEM
STRYKER IRELAND LTD., INSTRUMENTS 510(k) NO: K073633(TRADITIONAL)
ATTN: COLETTE O'CONNOR PHONE NO : 353 21 4532978
CARRIGTWOHILL BUSINESS & SE DECISION MADE: 26-AUG-08
TECHNOLOGY PARK 510(k) SUMMARY AVAILABLE FROM FDA
CARRIGTWOHILL, CO.CORK, IRELAND
DEVICE: DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES
SUNRISE MEDICAL 510(k) NO: K081468(TRADITIONAL)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 814-443-7602
100 DEVILBISS DR. SE DECISION MADE: 25-AUG-08
SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE
SURGICAL CONCEPT DESIGNS 510(k) NO: K081476(TRADITIONAL)
ATTN: CHRISTOPHER SCOTT PHONE NO : 201-456-9164
307 PROSPECT AVENUE SE DECISION MADE: 08-AUG-08
SUITE 2G 510(k) SUMMARY AVAILABLE FROM FDA
HACKENSACK, NJ 07601
DEVICE: SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EX
SYNTHES (USA) 510(k) NO: K082148(TRADITIONAL)
ATTN: JILL R SHERMAN PHONE NO : 610-719-6538
1301 GOSHEN PKWY. SE DECISION MADE: 11-AUG-08
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
SYSMEX AMERICA, INC. 510(k) NO: K081610(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 29-AUG-08
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K081445(TRADITIONAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 11-AUG-08
WUGU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI COUNTY, CHINA (TAIWAN) 248
DEVICE: U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K081957(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 05-AUG-08
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: BIOACTIF OSTEOTRANS INTERFENCE SCREW
TAKIRON CO., LTD 510(k) NO: K081390(TRADITIONAL)
ATTN: KUNIHIRO HATA PHONE NO : 81 78 3062601
7-1-19, MINATOJIMAMINAMIMACHI, SE DECISION MADE: 12-AUG-08
CHUO-KU 510(k) SUMMARY AVAILABLE FROM FDA
KOBE, HYOGO, JAPAN 650-0047
DEVICE: HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
TE ME NA SAS 510(k) NO: K080603(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO :
962 ALLEGRO LANE SE DECISION MADE: 05-AUG-08
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPACITY + BONE CEMENT
TEKNIMED SA 510(k) NO: K080873(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 28-AUG-08
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "LOVE GUARD" MALE LATEX CONDOM
TIANJIN HUMAN-CARE LATEX CORPORATI510(k) NO: K080833(ABBREVIATED)
ATTN: SIMON LI PHONE NO : 609-649-2723
56 DANVILLE DRIVE SE DECISION MADE: 07-AUG-08
WEST WINDSOR, NJ 08550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HI-ART TREATMENT SYSTEM
TOMOTHERAPY INCORPORATED 510(k) NO: K082005(TRADITIONAL)
ATTN: ROBERT BOVY PHONE NO : 608-824-2938
1209 DEMING WAY SE DECISION MADE: 25-AUG-08
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K082119(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR SE DECISION MADE: 12-AUG-08
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PCA-8000A, MARK 11, PET / CT SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K082244(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 21-AUG-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: TRAUSON BONE PLATE
TRAUSON (JIANGSU) MEDICAL INSTRUME510(k) NO: K073432(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467
LANE 999, ZHONGSHAN NO. 2 ROAD SE DECISION MADE: 13-AUG-08
SUITE 8D, NO. 19 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: CENTURION PROTECTIVE RESTRAINT, SCR SERIES
TRI-STATE HOSPITAL SUPPLY CORP. 510(k) NO: K080448(TRADITIONAL)
ATTN: MATTHEW K PRICE PHONE NO : 517-546-5400
301 CATRELL DR. SE DECISION MADE: 28-AUG-08
HOWELL, MI 48843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGER CANNULATED SCREW SYSTEM
TRILLIANT SURGICAL LTD 510(k) NO: K081510(TRADITIONAL)
ATTN: J. D WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 04-AUG-08
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 9
TRIMLINE MEDICAL PRODUCTS CORP. 510(k) NO: K080189(ABBREVIATED)
ATTN: NANCY SKOCYPEC PHONE NO : 908-429-0590
34 COLUMBIA AVE. SE DECISION MADE: 15-AUG-08
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: TRITON MEIDCAL TMED IV-SET
TRITON MEDICAL, LLC 510(k) NO: K073444(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 18-AUG-08
AUSTIN, TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
TRUDELL MEDICAL INTL. 510(k) NO: K080926(TRADITIONAL)
ATTN: DARRYL FISCHER PHONE NO : 519 455 7060 2140
725 THIRD ST. SE DECISION MADE: 12-AUG-08
LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT
DEVICE: TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
TYSON BIORESEARCH, INC. 510(k) NO: K081726(TRADITIONAL)
ATTN: WEN-HAI TSAI PHONE NO : 886 37 585988
5 F., # 22, KE TUNG RD., SE DECISION MADE: 26-AUG-08
SCIENCE BASED INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350
DEVICE: MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
U-SYSTEM, INC. 510(k) NO: K080930(TRADITIONAL)
ATTN: LISA SCOTT PHONE NO : 408-571-0777
110 ROSE ORCHARD WAY SE DECISION MADE: 07-AUG-08
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONIX MDP ULTRASOUND SCANNER
ULTRASONIX MEDICAL CORPORATION 510(k) NO: K080935(TRADITIONAL)
ATTN: ALAN REMFRY PHONE NO : 604 437 9500
130-4311 VIKING WAY SE DECISION MADE: 06-AUG-08
RICHMOND, BRITISH COLUMBIA, CANADA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERIES SY DISPOSABLE ELECTROSURGICAL PAD
VENTLAB CORP. 510(k) NO: K082204(TRADITIONAL)
ATTN: CHRISTINA NORRIS PHONE NO : 410-451-0639
1676 VILLAGE GREEN STE A SE DECISION MADE: 13-AUG-08
CROFTON, MD 21114-4341 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: PROVENT NASAL CANNULA
VENTUS MEDICAL, INC. 510(k) NO: K080983(TRADITIONAL)
ATTN: CINDY DOMECUS PHONE NO : 650-343-4813
1301 SHOREWAY ROAD SE DECISION MADE: 07-AUG-08
SUITE 340 510(k) SUMMARY AVAILABLE FROM FDA
BELMONT, CA 94002
DEVICE: VERISTA IMAGING ISOCAM II GAMMA CAMERA
VERISTA IMAGING INC. 510(k) NO: K081757(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 15-AUG-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: VIP PULMONARY FUNCTION SYSTEM
VIASYS HEALTHCARE GMBH 510(k) NO: K080510(SPECIAL)
ATTN: THOMAS RUST PHONE NO : 499 314 972383
LEIBNIZSTRASSE 7 SE DECISION MADE: 20-AUG-08
HOECHBERG, GERMANY 97204 510(k) STATEMENT
DEVICE: NEUROCATH AG
VYGON NEURO 510(k) NO: K081942(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE. SE DECISION MADE: 12-AUG-08
NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K082356(SPECIAL)
ATTN: ALICIA HEMPHILL PHONE NO : 928-864-4328
3450 WEST KILTIE LANE SE DECISION MADE: 28-AUG-08
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODEL
WALLAC OY 510(k) NO: K071649(TRADITIONAL)
ATTN: CINDY LLOYD PHONE NO : 781-663-5818
940 WINTER STREET SE DECISION MADE: 07-AUG-08
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEBERNEEDLE BASIC LASER
WEBER MEDICAL GMBH 510(k) NO: K073352(TRADITIONAL)
ATTN: JURGEN HERMANN PHONE NO : 499 856 922959
SOHNREYSTRASSE 6 SE DECISION MADE: 11-AUG-08
LAURENFORDE, NIEDERSACHSEN, GERMAN510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ANEROID SPHYGMOMANOMETER, MODEL KT-A01
WENZHOU KINDCARE IMPORT & EXPORT C510(k) NO: K081951(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 15-AUG-08
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WESTAR SERIES DENTAL UNITS
WESTAR MEDICAL PRODUCTS, INC. 510(k) NO: K082294(TRADITIONAL)
ATTN: RUTH HALLER PHONE NO : 425-290-3945
4470 CHENNAULT BEACH RD SE DECISION MADE: 22-AUG-08
SUITE 2 510(k) STATEMENT
MUKILTEO, WA 98275 THIRD PARTY REVIEW
DEVICE: WINCO MODEL POWER SERIES LIFT CHAIR
WINCO, INC. 510(k) NO: K080533(TRADITIONAL)
ATTN: JIM ANKOVIAK PHONE NO : 352-854-2929
5516 S.W. FIRST LN. SE DECISION MADE: 11-AUG-08
OCALA, FL 34474 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBOCARE 2000
XANACARE TECHNOLOGIES, LLC 510(k) NO: K081141(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-463-0900
13605 W. 7TH AVE. SE DECISION MADE: 29-AUG-08
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOMAP MOLECULAR EXPRESSION TESTING
XDX 510(k) NO: K073482(TRADITIONAL)
ATTN: ROSE ROMEO PHONE NO : 415-287-2396
3260 BAYSHORE BOULEVARD SE DECISION MADE: 08-AUG-08
BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIP
XODUS MEDICAL, INC. 510(k) NO: K081647(TRADITIONAL)
ATTN: BRENDA NIEL PHONE NO : 724-337-5500
702 PROMINENCE DR. SE DECISION MADE: 12-AUG-08
NEW KENSINGTON, PA 15068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
ZIMMER, INC. 510(k) NO: K073499(TRADITIONAL)
ATTN: ERIC S PITTMAN PHONE NO : 574-371-8369
P.O. BOX 708 SE DECISION MADE: 07-AUG-08
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 244
TOTAL WITH SUMMARIES 220
TOTAL WITH STATEMENTS 24
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