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Medical Devices
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October 2007 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-OCT-2007 THROUGH 31-OCT-2007
DEVICE: PIONEER CATHETER
MEDTRONIC INC. 510(k) NO: K072155(TRADITIONAL)
ATTN: CATHERINE PRIESTLEY PHONE NO : 707-591-7205
3576 UNOCAL PLACE SE DECISION MADE: 05-OCT-07
SANTA ROSA, CA 95403-1774 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOX SV PTA CATHETER
ABBOT LABORATORIES 510(k) NO: K072824(SPECIAL)
ATTN: GEORGE J PRENDERGAST PHONE NO : 408-845-0568
3200 LAKESIDE DRIVE SE DECISION MADE: 23-OCT-07
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM
ACE VISION GROUP 510(k) NO: K070296(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 512-327-9997
1101 SOUTH CAPITAL TEXAS HWY. SE DECISION MADE: 03-OCT-07
SUITE F254 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: ACON UTI URINARY TRACT INFECTION TEST STRIPS
ACON LABORATORIES, INC. 510(k) NO: K063295(TRADITIONAL)
ATTN: JINN-NAN LIN PHONE NO : 858-875-8028
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 12-OCT-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
ACTIVATOR METHODS INTERNATIONAL, L510(k) NO: K072519(TRADITIONAL)
ATTN: DEBBIE KOENEMAN PHONE NO : 602-481-5777
2751 E. HALE STREET SE DECISION MADE: 23-OCT-07
MESA, AZ 85313 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600
ADVANCED BRAIN MONITORING, INC. 510(k) NO: K071230(SPECIAL)
ATTN: DANIEL J LEVENDOWSKI PHONE NO : 760-720-0099
2237 FARADAY AVENUE SE DECISION MADE: 03-OCT-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92008
DEVICE: WIDE SPACED QUATTRODE LEADS
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K072462(SPECIAL)
ATTN: MIA M WARE PHONE NO : 972-309-8599
6901 PRESTON RD. SE DECISION MADE: 11-OCT-07
PLANO, TX 75024 510(k) STATEMENT
DEVICE: DRYSTAR AXYS, MODEL EYZ4E
AGFA HEALTHCARE CORPORATION 510(k) NO: K072680(SPECIAL)
ATTN: PATRICK J LYNCH PHONE NO : 864-421-1987
10 SOUTH ACADEMY ST. SE DECISION MADE: 25-OCT-07
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
AHLSTROM MOUNT HOLLY SPRINGS LLC 510(k) NO: K062932(ABBREVIATED)
ATTN: HEATHER MOWERS PHONE NO : 717-486-3438
122 WEST BUTLER ST. SE DECISION MADE: 19-OCT-07
MOUNT HOLLY SPRINGS, PA 17007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLVE UVB PHOTOTHERAPY SYSTEM
ALLUX MEDICAL 510(k) NO: K072035(TRADITIONAL)
ATTN: LLOYD H GRIESE PHONE NO : 650-473-9407
1430 O'BRIEN DRIVE SE DECISION MADE: 16-OCT-07
SUITE F 510(k) SUMMARY AVAILABLE FROM FDA
MENLO PARK, CA 94025
DEVICE: ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS
ALMA LASERS LTD. 510(k) NO: K072699(SPECIAL)
ATTN: A WORDEN PHONE NO : 925-895-1200
3637 BERNAL AVE. SE DECISION MADE: 05-OCT-07
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K072081(TRADITIONAL)
ATTN: MARY STANNERS PHONE NO : 760-494-6771
2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 24-OCT-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: VALEO CERVICAL PLATE SYSTEM
AMEDICA CORP. 510(k) NO: K071990(TRADITIONAL)
ATTN: GLENN STIEGMAN PHONE NO : 202-552-5800
1331 H ST. NW, 12TH FLOOR SE DECISION MADE: 29-OCT-07
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSURE NEBULIZER
AMSINO INTERNATIONAL, INC. 510(k) NO: K070411(TRADITIONAL)
ATTN: CHING C SEAH PHONE NO : 909-626-5888
855 TOWNE CENTER DR. SE DECISION MADE: 01-OCT-07
POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANSCOPE XT SYSTEM
APERIO TECHNOLOGIES 510(k) NO: K071128(TRADITIONAL)
ATTN: PERRY JOHNSTON PHONE NO : 760-539-1142
1430 VANTAGE COURT, SUITE 106 SE DECISION MADE: 10-OCT-07
VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPANDING VASCULAR SHEATH
APPLIED MEDICAL 510(k) NO: K070865(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESA SE DECISION MADE: 23-OCT-07
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KII TROCAR SYSTEM
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K072674(TRADITIONAL)
ATTN: FRANS VANDENBROEK PHONE NO : 949-713-8000
22872 AVENIDA EMPRESA SE DECISION MADE: 05-OCT-07
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SCANVIEW, MODEL SC-300
APPLIED SPECTRAL IMAGING, LTD. 510(k) NO: K071398(TRADITIONAL)
ATTN: SILVIA STOLARSKI PHONE NO : 972 465 47567
HAMATECHET ST 4. SE DECISION MADE: 04-OCT-07
RAMAT GAVRIEL, ISRAEL 10551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW INTERNATIONAL, INC., SURGICAL DRAPES
ARROW INTL., INC. 510(k) NO: K071491(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 10-OCT-07
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATON TO: ARTHROCARE ARTHROWANDS
ARTHROCARE CORP. 510(k) NO: K072865(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 23-OCT-07
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP1403
ASAHI INTECC CO., LTD. 510(k) NO: K072705(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
2500 RED HILL AVE, SUITE 210 SE DECISION MADE: 23-OCT-07
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K063788(TRADITIONAL)
ATTN: KATIE BRAY PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 15-OCT-07
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED TROCARS
ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K070059(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5394
10232 SOUTH 51ST ST. SE DECISION MADE: 02-OCT-07
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
ASTRA TECH AB 510(k) NO: K072624(SPECIAL)
ATTN: LINDA SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL, SE DECISION MADE: 01-OCT-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMP
ATLANTIS COMPONENTS, INC. 510(k) NO: K071946(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 05-OCT-07
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS SPINE PEDICLE SCREW SYSTEM
ATLAS SPINE LLC 510(k) NO: K072426(TRADITIONAL)
ATTN: JEANETTE G DAILEY PHONE NO : 561-354-4319
1555 JUPITER PARK DR., STE. 4 SE DECISION MADE: 19-OCT-07
JUPITER, FL 33458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR
AXYA MEDICAL, INC. 510(k) NO: K070773(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
100 CUMMINGS CENTER SE DECISION MADE: 11-OCT-07
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R
BARKEY GMBH & CO. KG 510(k) NO: K071909(ABBREVIATED)
ATTN: THOMAS BARKEY PHONE NO : 495 202 98010
GEWERBESTRASSE 8 SE DECISION MADE: 18-OCT-07
LEOPOLDSHOEHE, GERMANY D-33818 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
BECKMAN COULTER, INC. 510(k) NO: K071681(SPECIAL)
ATTN: LOURDES COBA PHONE NO : 305-380-4079
11800 SW 147TH AVE. SE DECISION MADE: 04-OCT-07
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S)
BECKMAN COULTER, INC. 510(k) NO: K072612(SPECIAL)
ATTN: RACHELLE PARSONS PHONE NO : 952-368-1227
1000 LAKE HAZELTINE DR. SE DECISION MADE: 26-OCT-07
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,G
BEIJING NORTH POLE DENTAL HANDPIEC510(k) NO: K071561(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
SUITE 8D, NO, 19 LANE 999, SE DECISION MADE: 12-OCT-07
ZHONGSHAN NO, 2 ROAD(S) 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24
BELIMED SAUTER AG 510(k) NO: K072087(TRADITIONAL)
ATTN: HANS STADLER PHONE NO : 41 71 6448500
ZELGSTRASSE 8 SE DECISION MADE: 05-OCT-07
SULGEN (TG), SWITZERLAND CH-8583 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYSTEM-MINI, MODELS: 390, E30
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K072294(SPECIAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 917 74300
PARKMORE BUSINESS PARK WEST SE DECISION MADE: 25-OCT-07
GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX VASCULITIS KIT
BIO-RAD LABORATORIES 510(k) NO: K072358(TRADITIONAL)
ATTN: PRIYA BONDRE PHONE NO : 425-881-8300
6565 185TH AVE, NE SE DECISION MADE: 31-OCT-07
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K071638(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 10-OCT-07
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM W
BIOLIFE, LLC 510(k) NO: K070520(TRADITIONAL)
ATTN: KAREN O'TOOLE PHONE NO : 941-360-1300
1235 TALLEVAST RD. SE DECISION MADE: 23-OCT-07
SARASOTA, FL 34243-3271 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS B.R.A.H.M.S. PCT ASSAY
BIOMERIEUX, INC. 510(k) NO: K071146(TRADITIONAL)
ATTN: NIKITA S MAPP PHONE NO : 314-731-7474
595 ANGLUM RD. SE DECISION MADE: 11-OCT-07
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE VANCOMYCIN
BIOMERIEUX, INC. 510(k) NO: K072668(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 15-OCT-07
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION K
BIOMET MANUFACTURING CORP. 510(k) NO: K071934(TRADITIONAL)
ATTN: MARY L VERSTYNEN PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 11-OCT-07
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET CABLE SYSTEM
BIOMET MANUFACTURING, INC. 510(k) NO: K071271(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 23-OCT-07
WARSAW, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACID ETCHED LAG SCREWS
BIOMET ORTHOPEDICS, INC. 510(k) NO: K070955(TRADITIONAL)
ATTN: BECKEY EARL PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 12-OCT-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPRO MEMORY STAPLE, MODELS 18062-18073
BIOPRO, INC. 510(k) NO: K072298(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 29-OCT-07
PORT HURON, MI 48060 510(k) STATEMENT
DEVICE: BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORI
BONART CO. LTD. 510(k) NO: K071981(TRADITIONAL)
ATTN: ERIC L ONG PHONE NO : 909-594-8066
398 S. LEMON CREEK DR. SE DECISION MADE: 26-OCT-07
STE. L 510(k) STATEMENT
WALNUT, CA 91789
DEVICE: BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
BRAEMAR, INC. 510(k) NO: K072008(TRADITIONAL)
ATTN: DARREN DERSHEM PHONE NO : 651-286-8629
1285 CORPORATE CENTER DR. SE DECISION MADE: 03-OCT-07
SUITE 150 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM
BRAINLAB AG 510(k) NO: K072046(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 899 915680
KAPELLENSTRASSE 12 SE DECISION MADE: 17-OCT-07
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTRAC 5.5
BRAINLAB AG 510(k) NO: K072506(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
KAPELLENSTRASSE 12 SE DECISION MADE: 26-OCT-07
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION HIP AND HIP SR
BRAINLAB AG 510(k) NO: K072573(SPECIAL)
ATTN: BENJAMIN WAGNER PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 11-OCT-07
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTOR VISION HIP
BRAINLAB AG 510(k) NO: K072716(SPECIAL)
ATTN: BENJAMIN WAGNER PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 12-OCT-07
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B,
BROADSOUND CORPORATION 510(k) NO: K070195(ABBREVIATED)
ATTN: JIANN HWA JENG, PHD PHONE NO : 886 355 39868
5F, NO.31 SHINTAI ROAD SE DECISION MADE: 15-OCT-07
JUIPEI CITY, HSINCHU, CHINA (TAIWA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPICC SOLO
C.R. BARD, INC. 510(k) NO: K072230(TRADITIONAL)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 05-OCT-07
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K072800(SPECIAL)
ATTN: JOHN CARLINE PHONE NO : 763-464-5026
18555 37TH AVE N SE DECISION MADE: 25-OCT-07
PLYMOUTH, MN 55446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)
CARLETON LIFE SUPPORT SYSTEMS INC.510(k) NO: K071904(TRADITIONAL)
ATTN: GARY BYRD PHONE NO : 563-383-6299
2734 HICKORY GROVE RD. SE DECISION MADE: 25-OCT-07
DAVENPORT, IA 52804-1203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPSEW PLICATION SYSTEM
CAYENNE MEDICAL, INC. 510(k) NO: K071796(TRADITIONAL)
ATTN: DAVID J COLLETTE PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 19-OCT-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: TROJAN-ENZ BRAND
CHURCH & DWIGHT CO., INC. 510(k) NO: K071313(ABBREVIATED)
ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-279-7748
469 NORTH HARRISON STREET SE DECISION MADE: 26-OCT-07
PRINCETON, NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX-STAR V
CMP INDUSTRIES LLC. 510(k) NO: K072402(TRADITIONAL)
ATTN: DEVON O HOWE PHONE NO : 518-434-3147
413 NORTH PEARL ST. SE DECISION MADE: 19-OCT-07
ALBANY, NY 12207 510(k) STATEMENT
DEVICE: CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
CODMAN & SHURTLEFF, INC. 510(k) NO: K071931(TRADITIONAL)
ATTN: EMILY E VALERIO PHONE NO : 508-828-3038
325 PARAMOUNT DR. SE DECISION MADE: 22-OCT-07
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
COEUR, INC. 510(k) NO: K070798(TRADITIONAL)
ATTN: DEBRA F MANNING PHONE NO : 615-547-7923
704 CADET COURT SE DECISION MADE: 04-OCT-07
LEBANON, TN 37087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNOSS SYNTHETIC BONE GRAFT MATERIAL
COLLAGEN MATRIX, INC. 510(k) NO: K072397(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 18-OCT-07
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFECT TISSUE CONTOURING SYSTEM II
COLTENE/WHALEDENT INC. 510(k) NO: K071632(ABBREVIATED)
ATTN: GLENN PERSELLO PHONE NO : 330-916-8837
235 ASCOT PARKWAY SE DECISION MADE: 18-OCT-07
CUYAHOGA FALLS, OH 44223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORT POWERED WHEELCHAIR, LY-EB 206
COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K072711(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO 58 FU-CHIUN ST. SE DECISION MADE: 31-OCT-07
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORT ELECTRIC SCOOTER, LY-EW408
COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K072712(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO 58 FU-CHIUN ST. SE DECISION MADE: 31-OCT-07
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMNISCREEN HOME DETECTION LINER KIT
COMMON SENSE, LTD. 510(k) NO: K071100(TRADITIONAL)
ATTN: NATASHA LESKOVSEK PHONE NO : 202-912-2719
1717 RHODE ISLAND AVE., NW SE DECISION MADE: 15-OCT-07
WASHINGTON, DC 20036-3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONACO RTP SYSTEM
COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K071938(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314-993-0003
1145 CORPORATE LAKE DR. SE DECISION MADE: 01-OCT-07
ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VCARE RETRACTOR/ELEVATOR
CONMED CORPORATION 510(k) NO: K071907(SPECIAL)
ATTN: BRIAN KILLORAN PHONE NO : 315-624-3219
525 FRENCH RD. SE DECISION MADE: 05-OCT-07
UTICA, NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPO
CONMED LINVATEC 510(k) NO: K072706(SPECIAL)
ATTN: SUE F DAUTERMAN PHONE NO : 727-399-5321
11311 CONCEPT BOULEVARD SE DECISION MADE: 24-OCT-07
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
COOK BIOTECH, INC. 510(k) NO: K070405(TRADITIONAL)
ATTN: DANIEL J DILLON PHONE NO : 765-463-7537
1400 CUMBERLAND AVE. SE DECISION MADE: 17-OCT-07
WEST LAFAYETTE, IN 47906 510(k) STATEMENT
DEVICE: CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTR
COOK, INC. 510(k) NO: K072148(SPECIAL)
ATTN: SUSANNE GALIN PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 03-OCT-07
BLOOMINGTON, IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAME READY CLASSIC SYSTEM, MODEL 550550
COOLSYSTEMS, INC. 510(k) NO: K072620(TRADITIONAL)
ATTN: MARIANNE BALDWIN PHONE NO : 510-868-5378
2201 DWIGHT WAY SE DECISION MADE: 31-OCT-07
BERKELEY, CA 94704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTECH PERCUTANEOUS INSERTION DILATOR KIT
COOMBS MEDICAL DEVICE CONSULTING 510(k) NO: K070749(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 510-337-0141
1193 SHERMAN STREET SE DECISION MADE: 24-OCT-07
ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPD LIQUID OXYGEN PORTABLE, MODEL 300P
COPD PARTNERS, INC. 510(k) NO: K072011(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. SE DECISION MADE: 18-OCT-07
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134-2015
DEVICE: MONOSWIFT
CP MEDICAL 510(k) NO: K072229(ABBREVIATED)
ATTN: BETSY CORTELLONI PHONE NO : 770-831-4294
5203 BRISTOL INDUSTRIAL WAY SE DECISION MADE: 05-OCT-07
BUFORD, GA 30518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBERWAND STERILE PADS, MODEL: CW-RBPBX
CYBERSONICS, INC. 510(k) NO: K072422(SPECIAL)
ATTN: WILLIAM A STOLL PHONE NO : 814-899-4220
5368 KUHL RD. SE DECISION MADE: 24-OCT-07
ERIE, PA 16510-4703 510(k) STATEMENT
DEVICE: INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
D B ORTHODONTICS LTD 510(k) NO: K072086(TRADITIONAL)
ATTN: ANNA M DYSON PHONE NO : 44 153 5656999
RYEFIELD WAY SE DECISION MADE: 26-OCT-07
SILSDEN, KEIGHLEY 510(k) STATEMENT
WEST YORKSHIRE, UNITED KINGDOM BD20 0EF
DEVICE: DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 C
DADE BEHRING, INC. 510(k) NO: K072435(TRADITIONAL)
ATTN: KATHLEEN ENNIS PHONE NO : 302-631-9352
P.O. BOX 6101 SE DECISION MADE: 17-OCT-07
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND P
DATEX-OHMEDA, INC. 510(k) NO: K072512(SPECIAL)
ATTN: AGATA SMIEJA PHONE NO : 410-888-5218
8880 GORMAN ROAD SE DECISION MADE: 03-OCT-07
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULTAN TOOTH ROOT DESENSITIZER
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K072342(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CTR., 221 SE DECISION MADE: 03-OCT-07
W. PHILADELPHIA ST., SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: ION DENTAL RESIN SYSTEM
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K072713(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST. SE DECISION MADE: 12-OCT-07
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: SMALL FRAGMENT LOCKING PLATING SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K072083(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305-328-3851
700 ORTHOPAEDIC DR. SE DECISION MADE: 25-OCT-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM
DEPUY SPINE,INC 510(k) NO: K072546(SPECIAL)
ATTN: FRANK S JURCZAK PHONE NO : 508-828-3288
325 PARAMONT DRIVE SE DECISION MADE: 05-OCT-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SPACE CPSXL BONE CEMENT
DFINE, INC. 510(k) NO: K072496(SPECIAL)
ATTN: ROBERT POSER PHONE NO : 408-321-9999
3047 ORCHARD PKWY. SE DECISION MADE: 05-OCT-07
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION A
DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K070265(TRADITIONAL)
ATTN: GAIL GOODRUM PHONE NO : 740-593-1784
350 WEST STATE ST. SE DECISION MADE: 24-OCT-07
ATHENS, OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN D
DIASORIN, INC. 510(k) NO: K071480(TRADITIONAL)
ATTN: CHARLES D KAFADER II PHONE NO : 651-351-5820
1951 NORTHWESTERN AVE. SE DECISION MADE: 01-OCT-07
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082-0285
DEVICE: TRACKPORT
DIREX SYSTEMS CORP. 510(k) NO: K072529(TRADITIONAL)
ATTN: LARISA GERSHTEIN PHONE NO : 339-502-6013
437 TURNPIKE ST. SE DECISION MADE: 26-OCT-07
CANTON, MA 02021 510(k) STATEMENT
DEVICE: BEMITT, MODEL 0001
DJA DISTRIBUTORS, LLC 510(k) NO: K071787(TRADITIONAL)
ATTN: GEORGE GLUMAC PHONE NO : 970-323-5440
540 HWY 50 BUSINESS LOOP SE DECISION MADE: 26-OCT-07
OLATHE, CO 81425 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GENERAL SEMEN ANALYSIS KIT
DYN-BIOSHAF (2006) LTD. 510(k) NO: K071737(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 25-OCT-07
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOWAVE INFUSION SYSTEM
EKOS CORP. 510(k) NO: K072507(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-415-3123
11911 N CREEK PARKWAY SOUTH SE DECISION MADE: 04-OCT-07
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HABIB VESEAL
EMCISION, LTD. 510(k) NO: K072126(TRADITIONAL)
ATTN: NAGY HABIB PHONE NO : 442 083 838574
LIVER SURGERY, HAMMERSMITH SE DECISION MADE: 02-OCT-07
HOSPITAL CAMPUS, DU CANE RD. 510(k) SUMMARY AVAILABLE FROM FDA
LONDON, UK, UNITED KINGDOM W12 OHSTHIRD PARTY REVIEW
DEVICE: DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES
ENCISION, INC. 510(k) NO: K072789(TRADITIONAL)
ATTN: JUDITH V KING PHONE NO : 303-440-9250
6797 WINCHESTER CIR. SE DECISION MADE: 19-OCT-07
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ERBE ERBEJET 2 SYSTEM
ERBE USA, INC. 510(k) NO: K072404(ABBREVIATED)
ATTN: JOHN TARTAL PHONE NO : 770-955-4400
2225 NORTHWEST PKWY. SE DECISION MADE: 31-OCT-07
MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS
ESCADA INTERNATIONAL, INC. 510(k) NO: K071445(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 29-OCT-07
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: A-BSM BONE SUBSTITUTE MATERIAL
ETEX CORP. 510(k) NO: K072636(SPECIAL)
ATTN: PAMELA W ADAMS PHONE NO : 617-577-7270
38 SIDNEY ST. SE DECISION MADE: 23-OCT-07
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20
FAXITRON X-RAY CORP. 510(k) NO: K072557(TRADITIONAL)
ATTN: DOUGLAS WIEGMAN PHONE NO : 847-465-9729
225 LARKIN DR.,SUITE 1 SE DECISION MADE: 30-OCT-07
WHEELING, IL 60090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL
FOCUS DIAGNOSTICS, INC. 510(k) NO: K071511(TRADITIONAL)
ATTN: SID MATHUR PHONE NO : 714-220-1900
10703 PROGRESS WAY SE DECISION MADE: 05-OCT-07
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALTSTICK INTRODUCER SYSTEM
GALT MEDICAL CORP. 510(k) NO: K071330(SPECIAL)
ATTN: DAVID CATLIN PHONE NO : 972-271-5177
2220 MERRITT DR. SE DECISION MADE: 31-OCT-07
GARLAND, TX 75041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMBRO CARTRIDGE BLOOD SETS
GAMBRO RENAL PRODUCTS 510(k) NO: K070414(TRADITIONAL)
ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094
10810 W. COLLINS AVE. SE DECISION MADE: 12-OCT-07
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATOR APPLICATIONS SUITE
GE HEALTHCARE FINLAND OY 510(k) NO: K071097(TRADITIONAL)
ATTN: ADRIENNE LENZ PHONE NO : 608-221-1551
3030 OHMEDA DRIVE SE DECISION MADE: 10-OCT-07
PO BOX 7550 510(k) SUMMARY AVAILABLE FROM FDA
MADISON, WI 53707-7550
DEVICE: GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, G
GENERAL ELECTRIC CO. 510(k) NO: K072797(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
9900 INNOVATION DRIVE SE DECISION MADE: 17-OCT-07
MAIL CODE: RP-2138 510(k) SUMMARY AVAILABLE FROM FDA
WAUWATOSA, WI 53226
DEVICE: ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
GENESEE BIOMEDICAL, INC. 510(k) NO: K072655(SPECIAL)
ATTN: JOHN T WRIGHT, PH.D. PHONE NO : 303-777-3000
1308 SOUTH JASON ST. SE DECISION MADE: 23-OCT-07
DENVER, CO 80223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIKO CORPECTOMY SPACER
GLOBUS MEDICAL INC. 510(k) NO: K072465(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 04-OCT-07
AUDUBON, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040
GLUSTITCH, INC. 510(k) NO: K071484(TRADITIONAL)
ATTN: DON BLACKLOCK PHONE NO : 800-667-2130
#307 7188 PROGRESS WAY SE DECISION MADE: 10-OCT-07
DELTA, B.C., CANADA V4G 1M6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM
GVI TECHNOLOGY PARTNERS 510(k) NO: K072191(TRADITIONAL)
ATTN: KEVIN M MURROCK PHONE NO : 330-963-4083
1470 ENTERPRISE PKWY. SE DECISION MADE: 25-OCT-07
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPHAEL COLOR ASV VENTILATOR
HAMILTON MEDICAL AG 510(k) NO: K071194(TRADITIONAL)
ATTN: JOERG SCHNEIDER PHONE NO : 41 81 6606479
VIA CRUSCH 8 SE DECISION MADE: 18-OCT-07
BONADUZ, SWITZERLAND CH-7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDC STERILE SPIDER SCREW
HDC S.R.L. 510(k) NO: K071851(TRADITIONAL)
ATTN: GUIDO BONAPACE PHONE NO : 39 051 6257315
VIA CALINDRI, 50 SE DECISION MADE: 18-OCT-07
SAN LAZZARO DI SAVENA, BOLOGNA, IT510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCUE WBC SYSTEM
HEMOCUE AB 510(k) NO: K071652(TRADITIONAL)
ATTN: ALLAN WHITE PHONE NO : 949-859-2630
40 EMPIRE DRIVE SE DECISION MADE: 25-OCT-07
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INRATIO 2 PT MONITORING SYSTEM
HEMOSENSE, INC. 510(k) NO: K072727(SPECIAL)
ATTN: DOUG RUNDLE PHONE NO : 408-240-3791
651 RIVER OAKS PARKWAY SE DECISION MADE: 26-OCT-07
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCELARREST FOAM
HEMOSTASIS, LLC 510(k) NO: K072900(SPECIAL)
ATTN: KEITH ROBERTS PHONE NO : 651-402-7705
5000 TOWNSHIP PARKWAY SE DECISION MADE: 26-OCT-07
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
HORIBA ABX 510(k) NO: K070146(TRADITIONAL)
ATTN: PASCAL MACZIOLA PHONE NO : 33 4 67141503
PARC EUROMEDECINE SE DECISION MADE: 12-OCT-07
RUE DU CADUCEE, BP 7290 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, FRANCE 34184
DEVICE: TRIATHLON PKR SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K071881(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DR. SE DECISION MADE: 09-OCT-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESTORATION ADM SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K072020(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 18-OCT-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TRIATHLON TS KNEE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K072221(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612
325 CORPORATE DR SE DECISION MADE: 15-OCT-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICU MEDICAL SINGLE-USE SYRINGE
ICU MEDICAL, INC 510(k) NO: K070856(ABBREVIATED)
ATTN: TRACY S BEST PHONE NO : 801-264-1332
4455 ATHERTON DR. SE DECISION MADE: 05-OCT-07
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION BIORESTORE
INION OY 510(k) NO: K070998(TRADITIONAL)
ATTN: KATI MARTTINEN PHONE NO : 358 108 306600
LAAKARINKATU 2 SE DECISION MADE: 11-OCT-07
TAMPERE, FINLAND FIN-33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE
INNOVATIVE SPINAL TECHNOLOGIES INC510(k) NO: K072120(TRADITIONAL)
ATTN: GINA YEH PHONE NO : 508-452-3500
111 FORBES BLVD. SE DECISION MADE: 11-OCT-07
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOMAX DS
INO THERAPEUTICS LLC 510(k) NO: K071516(SPECIAL)
ATTN: RICHARD K BOURNE PHONE NO : 908-238-6312
6 ROUTE 173 SE DECISION MADE: 03-OCT-07
CLINTON, NJ 08809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P.004 ABUTMENTS
INSTITUT STRAUMANN AG 510(k) NO: K072679(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 12-OCT-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
INTEGRA LIFESCIENCES CORP. 510(k) NO: K072113(TRADITIONAL)
ATTN: DIANA M BORDON PHONE NO : 609-936-2240
311C ENTERPRISE DRIVE SE DECISION MADE: 10-OCT-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS
INTEGRA RADIONICS, INC. 510(k) NO: K072454(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-565-1227
22 TERRY AVENUE SE DECISION MADE: 16-OCT-07
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
INTERNATIONAL MEDICAL DEVELOPMENT,510(k) NO: K070354(TRADITIONAL)
ATTN: WALTER ZOHMANN PHONE NO : 801-745-4700
9202 KELLEY DRIVE SE DECISION MADE: 05-OCT-07
P.O. BOX 510 510(k) SUMMARY AVAILABLE FROM FDA
HUNTSVILLE, UT 84317
DEVICE: MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM
INTRA-LOCK INTERNATIONAL 510(k) NO: K070601(TRADITIONAL)
ATTN: JEFFREY SAKOFF PHONE NO : 561-447-8282
1200 NORTH FEDERAL HWY. SE DECISION MADE: 12-OCT-07
SUITE 209 510(k) SUMMARY AVAILABLE FROM FDA
BOCA RATON, FL 33432
DEVICE: PTFE PEEL AWAY MICROINTRODUCER
INTROMED 510(k) NO: K072130(TRADITIONAL)
ATTN: PHIL TRIOLO PHONE NO : 801-328-1996
148 S. 1200 E. SE DECISION MADE: 31-OCT-07
SALT LAKE CITY, UT 84102 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROBE HOLDER SYSTEM
INTUITIVE SURGICAL, INC. 510(k) NO: K071405(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 09-OCT-07
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K070751(TRADITIONAL)
ATTN: KARON MORELL PHONE NO : 949-855-7168
2 GOODYEAR, SUITE B SE DECISION MADE: 15-OCT-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BIOSTAR OIA SHIGATOX
IVERNESS MEDICAL PROFESSIONAL DIAG510(k) NO: K071799(TRADITIONAL)
ATTN: ROBIN C HART PHONE NO : 303-530-6612
331 SOUTH 104TH ST. SE DECISION MADE: 02-OCT-07
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTLERAY 980 DIODE LASER SYSTEM
KAVO AMERICA 510(k) NO: K072262(TRADITIONAL)
ATTN: JOHN MILLER PHONE NO : 847-364-3931
340 EAST MAIN ST. SE DECISION MADE: 26-OCT-07
LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OLYMPUS DENTAL IMPLANT SYSTEM
KEYSTONE DENTAL, INC. 510(k) NO: K071070(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, SE DECISION MADE: 23-OCT-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: KFX TISSUE FIXATION SYSTEM AND ACCESSORIES
KFX MEDICAL 510(k) NO: K072063(TRADITIONAL)
ATTN: M D HEAVEN PHONE NO : 619-270-8478
5145 AVENIDA ENCINAS, SUITE C SE DECISION MADE: 26-OCT-07
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORU, MODEL EQ30
KWANG YANG MOTOR CO., LTD. 510(k) NO: K072630(TRADITIONAL)
ATTN: JUANNATA CHANG PHONE NO : 886 422 465396
14F-2, NO.1, ZHUANGJING ROAD SE DECISION MADE: 03-OCT-07
LANE 25 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: POLYPERF / POLYPERF SAFE
LABORATOIRES PEROUSE 510(k) NO: K063631(TRADITIONAL)
ATTN: MARIE NOELLE EROUT PHONE NO : 333 440 81707
ROUTE DU MANOIR SE DECISION MADE: 05-OCT-07
IVRY LE TEMPLE, FRANCE 60173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT
LEONHARD LANG GMBH 510(k) NO: K072233(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 05-OCT-07
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS
LIFE-TECH, INC. 510(k) NO: K072050(TRADITIONAL)
ATTN: JEFF KASOFF PHONE NO : 281-491-6600
4235 GREENBRIAR DR. SE DECISION MADE: 18-OCT-07
STAFFORD, TX 77477-3995 510(k) STATEMENT
DEVICE: LTM-RC SURGICAL MESH
LIFECELL CORP. 510(k) NO: K071986(TRADITIONAL)
ATTN: LORRAINE T MONTEMURRO PHONE NO : 908-947-1115
ONE MILLENNIUM WAY SE DECISION MADE: 19-OCT-07
BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS
LIFECORE BIOMEDICAL, INC. 510(k) NO: K072572(SPECIAL)
ATTN: KAREN CLEMENT PHONE NO : 952-368-6294
3515 LYMAN BLVD. SE DECISION MADE: 05-OCT-07
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLAN
LIFECORE BIOMEDICAL, INC. 510(k) NO: K072768(SPECIAL)
ATTN: KAREN CLEMENT PHONE NO : 952-368-4300
3515 LYMAN BLVD. SE DECISION MADE: 23-OCT-07
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K072543(SPECIAL)
ATTN: ALISON WILSON PHONE NO : 408-263-9789
1000 GIBRALTAR DR. SE DECISION MADE: 05-OCT-07
MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
LINA MEDICAL APS 510(k) NO: K070315(TRADITIONAL)
ATTN: WALT BRITTLE PHONE NO : 919-942-1634
1289 N. FORDHAM BLVD. SE DECISION MADE: 30-OCT-07
SUITE A-128 510(k) SUMMARY AVAILABLE FROM FDA
CHAPEL HILL, NC 27517
DEVICE: CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
MEDICAL DECISIONS NETWORK 510(k) NO: K071713(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5600
555 THIRTEENTH STREET, NW SE DECISION MADE: 12-OCT-07
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEXAPOD EVO RT COUCH TOP
MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K072898(SPECIAL)
ATTN: MICHAEL WOLFF PHONE NO : 490 823 29692701
ROBERT-BOSCH-STRASSE 8 SE DECISION MADE: 25-OCT-07
SCHWABMUNCHEN, GERMANY 86830 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
MEDICAL SELECT, INC. 510(k) NO: K072097(TRADITIONAL)
ATTN: AMY JONES PHONE NO : 919-388-3360
120 SOUTHCENTER CT., SUITE 400 SE DECISION MADE: 30-OCT-07
MORRISVILLE, NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIPKNOT, MODEL 1017-3000
MEDICINELODGE, INC. 510(k) NO: K072525(SPECIAL)
ATTN: MARY SINNOTT PHONE NO : 435-774-1503
180 SOUTH 600 WEST SE DECISION MADE: 05-OCT-07
LOGAN, UT 84321 510(k) STATEMENT
DEVICE: MODIFICATION TO PASSMED SPINAL SYSTEM
MEDICREA TECHNOLOGIES 510(k) NO: K070530(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 18-OCT-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
MEDTEXX MANUFACTURING SDN. BHD. 510(k) NO: K071740(TRADITIONAL)
ATTN: OOI LOON SENG PHONE NO : 605 891 1111
PT 4004 KAMUNTING INDU. ESTATE SE DECISION MADE: 04-OCT-07
KAMUNTING, TAIPING, PERAK, MALAYSI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
MEDTRONIC INC. 510(k) NO: K072990(TRADITIONAL)
ATTN: KAREN A BROZOWSKI PHONE NO : 978-777-0042
37A CHERRY HILL DRIVE SE DECISION MADE: 31-OCT-07
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
MEDTRONIC MINIMED, INC. 510(k) NO: K070438(TRADITIONAL)
ATTN: JODIE ROGERS PHONE NO : 818-576-5708
18000 DEVONSHIRE STREET SE DECISION MADE: 17-OCT-07
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAVERSE OCT SPINAL FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K062447(TRADITIONAL)
ATTN: ED CHIN PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 15-OCT-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUCTION COAGULATOR
MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K072559(TRADITIONAL)
ATTN: RONDA MAGNESON PHONE NO : 801-576-9669
11506 SOUTH STATE ST. SE DECISION MADE: 05-OCT-07
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIS MODULE FOR ENVOY PATIENT MONITOR
MENNEN MEDICAL LTD. 510(k) NO: K071899(TRADITIONAL)
ATTN: IFAT OREN PHONE NO : 972 8 9323333
4 HAYARDEN ST., YAVNE SE DECISION MADE: 22-OCT-07
P.O.BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: TRU RSV
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K071101(TRADITIONAL)
ATTN: SUSAN ROLIH PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 18-OCT-07
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METOXIT CAM-BLANKS
METOXIT AG 510(k) NO: K072569(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 31-OCT-07
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: E3-80 PORTABLE ECG RECORDER & ANALYZER
MICRO-STAR INTERNATIONAL CO., LTD.510(k) NO: K071085(TRADITIONAL)
ATTN: ALBUM D TSAI PHONE NO : 011 886 968250253
NO. 69, LI-DE STREET SE DECISION MADE: 03-OCT-07
JUNG-HE CITY, TAIPEI HSIEN, CHINA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMLAB
MICROPACE PTY. LTD. 510(k) NO: K072200(TRADITIONAL)
ATTN: MICHAEL CEJNAR PHONE NO : 610 297 181746
7/186-188 CANTERBURY ROAD SE DECISION MADE: 26-OCT-07
CANTERBURY, NSW, AUSTRALIA 2193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS MICROCOIL SYSTEM "CASHMERE-CERECYTE", MODEL CRC; "CASHMER
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K072173(SPECIAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1400
821 FOX LANE SE DECISION MADE: 05-OCT-07
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS COURIER ENZO MICROCATHETER 0.0190
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K072526(SPECIAL)
ATTN: MICHAEL CROMPTON PHONE NO : 650-678-7593
821 FOX LANE SE DECISION MADE: 05-OCT-07
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR
MIDMARK DIAGNOSTICS GROUP 510(k) NO: K072516(TRADITIONAL)
ATTN: TONY CAPPARELLI PHONE NO : 310-257-7217
3300 FUJITA STREET SE DECISION MADE: 18-OCT-07
TORRANCE, CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIGHT SABRE SPINAL ACCESS DEVICE
MINRAD, INC. 510(k) NO: K071814(TRADITIONAL)
ATTN: JOHN MCNEIRNEY PHONE NO : 716-855-1068
50 COBHAM DR. SE DECISION MADE: 16-OCT-07
ORCHARD PARK, NY 14127-4121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINRAD INC. NASAL SCAVENGING CIRCUIT
MINRAD, INC. 510(k) NO: K072255(TRADITIONAL)
ATTN: JOHN MCNEIMEY PHONE NO : 716-855-1068
50 COBHAM DR. SE DECISION MADE: 18-OCT-07
ORCHARD PARK, NY 14127-4121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICAL MAGGOTS, CREATURE COMFORTS
MONARCH LABS, LLC. 510(k) NO: K072438(TRADITIONAL)
ATTN: RONALD S SHERMAN PHONE NO : 949-679-3000
17875 SKY PARK CIRCLE, SUITE K SE DECISION MADE: 05-OCT-07
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MC 3003G-32R HEAD COIL
MR INSTRUMENTS, INC. 510(k) NO: K072931(TRADITIONAL)
ATTN: MARK WATSON PHONE NO : 952-746-1435
5610 ROWLAND ROAD SE DECISION MADE: 30-OCT-07
SUITE 145 510(k) SUMMARY AVAILABLE FROM FDA
MINNETONKA, MN 55343 THIRD PARTY REVIEW
DEVICE: NGARDE SYSTEM
N SPINE, INC. 510(k) NO: K072685(SPECIAL)
ATTN: JUDE V PAGANELLI PHONE NO : 858-452-1266
6244 FERRIS SQUARE, SUITE B SE DECISION MADE: 19-OCT-07
SAN DIEGO, CA 92121-3239 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND
NANOSPHERE, INC 510(k) NO: K070597(TRADITIONAL)
ATTN: SUE KENT PHONE NO : 847-400-9000
4088 COMMERCIAL AVENUE SE DECISION MADE: 11-OCT-07
NORTHBROOK, IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
NDO SURGICAL, INC. 510(k) NO: K072125(TRADITIONAL)
ATTN: JOHN J VOZELLA PHONE NO : 508-337-8881
125 HIGH ST., SE DECISION MADE: 18-OCT-07
SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA
MANSFIELD, MA 02048
DEVICE: NEOSS VARIOUS TITANIUM ABUTMENTS
NEOSS LTD 510(k) NO: K071838(TRADITIONAL)
ATTN: FREDRIK ENGMAN PHONE NO : 441 423 817733
WINDSOR HOUSE, CORNWALL ROAD SE DECISION MADE: 19-OCT-07
HARROGATE, UNITED KINGDOM HGI2PW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUVIZ SPIRAL CT SCANNER SYSTEM
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K072841(TRADITIONAL)
ATTN: TIAN TANFANG PHONE NO : 862 483 660649
NO.3-11, WENHUA ROAD SE DECISION MADE: 16-OCT-07
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW
DEVICE: PHENIX VERTEBRAL BODY REPLACEMENT
NEW BUSINESS DEVELOPMENT, LLC 510(k) NO: K072029(TRADITIONAL)
ATTN: TIM B LUSBY PHONE NO : 770-874-0935
1155 ALLGOOD RD. SE DECISION MADE: 15-OCT-07
SUITE 6 510(k) SUMMARY AVAILABLE FROM FDA
MARIETTA, GA 30062
DEVICE: COOLTOUCH, MODEL LC215,COOLLIPO
NEW STAR LASERS, INC. 510(k) NO: K072424(SPECIAL)
ATTN: NATALIE VOLLRATH PHONE NO : 916-677-1900
9085 FOOTHILLS BLVD. SE DECISION MADE: 03-OCT-07
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901
NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K071384(TRADITIONAL)
ATTN: KOJI KUBO PHONE NO : 814 254 81253
3F, 2-17-6 AKEBONO-CHO SE DECISION MADE: 09-OCT-07
TACHIKAWA- SHI, JAPAN 190-0012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
NIPRO MEDICAL CORP. 510(k) NO: K072024(SPECIAL)
ATTN: JESSICA OSWALD PHONE NO : 305-599-7174
3150 NW 107 AVE.. SE DECISION MADE: 04-OCT-07
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
NOVALUNG GMBH 510(k) NO: K072362(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-OCT-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REALHAND HIGH DEXTERITY INSTRUMENTS
NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K072715(SPECIAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-768-0247
1070 CONCORD AVE., SUITE 230 SE DECISION MADE: 16-OCT-07
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVOFLO CATHETER LT
NOVOSCI, INC. 510(k) NO: K072499(TRADITIONAL)
ATTN: DAVID MAKANANI PHONE NO : 405-826-0713
2828 NORTH CRESCENT RIDGE DR. SE DECISION MADE: 30-OCT-07
THE WOODLANDS, TX 77381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
NUVASIVE, INC. 510(k) NO: K072339(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE COURT SE DECISION MADE: 19-OCT-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROVISION JJB SYSTEM
NUVASIVE, INC. 510(k) NO: K072343(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE COURT SE DECISION MADE: 29-OCT-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360
OBTECH MEDICAL SARL 510(k) NO: K071764(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146
4545 CREEK RD. SE DECISION MADE: 24-OCT-07
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAL NEUTRALIZER
ORAL BIOTECH 510(k) NO: K071617(TRADITIONAL)
ATTN: ROBERT BOWERS PHONE NO : 541-928-4445
812 WATER ST. NE SE DECISION MADE: 19-OCT-07
ALBANY, OR 97321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNIRAY 5.2
ORANGEDENTAL GMBH & CO. KG 510(k) NO: K072665(TRADITIONAL)
ATTN: MARC FIEBER PHONE NO : 49 735 1474990
IM FORSTGARTEN 11 SE DECISION MADE: 03-OCT-07
BIBERACH, GERMANY 88400 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE
ORIDION CAPNOGRAPHY, INC. 510(k) NO: K072295(SPECIAL)
ATTN: RACHEL WEISSBROD PHONE NO : 972 258 99115
HAMARPE 7 SE DECISION MADE: 11-OCT-07
JERUSALEM, ISRAEL 91450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYTOPLAST PTFE SUTURE
OSTEOGENICS BIOMEDICAL, INC. 510(k) NO: K072076(ABBREVIATED)
ATTN: DUSTYN WEBB PHONE NO : 806-796-1923
4620 71ST ST., BLDG. 78-79 SE DECISION MADE: 31-OCT-07
LUBBOCK, TX 79424 510(k) STATEMENT
DEVICE: CITOP10 GUIDEWIRE, 0.014"(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014"(1
OVALUM LTD. 510(k) NO: K070212(TRADITIONAL)
ATTN: KEN RAICHMAN PHONE NO : 972 893 15679
10, PLAUT ST. RABIN PARK SE DECISION MADE: 12-OCT-07
REHOVOT, ISRAEL 76706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOP-B SYSTEM, VERSION 2.1
PAIEON, INC. 510(k) NO: K072591(SPECIAL)
ATTN: RAVIT BARKAMA PHONE NO : 972 391 50000
22 HAMELACHA ST., P.O.B. 11355 SE DECISION MADE: 10-OCT-07
ROSH HAAYIN, ISRAEL 48901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APACERAM BONE GRAFT SUBSTITUTE
PENTAX CORP. 510(k) NO: K071912(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5600 WISCONSIN AVENUE SE DECISION MADE: 29-OCT-07
SUITE 509 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815
DEVICE: ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K072545(TRADITIONAL)
ATTN: GREG MOREAU PHONE NO : 203-265-7397
68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 26-OCT-07
ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: T-PORT HP INFUSION PORT
PFM MEDICAL, INC 510(k) NO: K071993(TRADITIONAL)
ATTN: SALVADORE PALOMARES PHONE NO : 760-758-8749
2605 TEMPLE HEIGHTS DRIVE SE DECISION MADE: 17-OCT-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
OCEANSIDE, CA 92056
DEVICE: POWRSYRINGE ASPIRATOR
PINYONS MEDICAL TECHNOLOGY, INC. 510(k) NO: K072299(TRADITIONAL)
ATTN: SHAWN P FOJTIK PHONE NO :
5010 HEUGA CT. SE DECISION MADE: 04-OCT-07
PARK CITY, UT 84098 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PIONEER LOWTOP SPINAL ROD SYSTEM
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K072187(TRADITIONAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 12-OCT-07
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTS PANELS CHOL+HDL PANEL TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K071593(SPECIAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 15-OCT-07
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
PROMEPLA 510(k) NO: K071421(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5600 WISCONSIN AVENUE SE DECISION MADE: 04-OCT-07
SUITE 509 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815
DEVICE: PULSION PICCO-2, MODEL 8500
PULSION MEDICAL SYSTEMS AG 510(k) NO: K072735(SPECIAL)
ATTN: JAMIE SULLEY PHONE NO : 919-562-4851
7220 SPARHAWK RD. SE DECISION MADE: 18-OCT-07
WAKE FOREST, NC 27587 510(k) STATEMENT
DEVICE: SPEEDER 1.5T WRIST ARRAY COIL
QUALITY ELECTRODYNAMICS 510(k) NO: K072935(TRADITIONAL)
ATTN: CHRISTIE ZYDYK PHONE NO : 440-484-2228
777 BETA DR. SE DECISION MADE: 31-OCT-07
MAYFIELD VILLAGE, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUANTRX FEMALE FERTILITY TEST
QUANTRX BIOMEDICAL CORPORATION 510(k) NO: K070484(TRADITIONAL)
ATTN: LORRAINE C COGAN PHONE NO : 858-774-4196
14033 STONEY GATE PLACE SE DECISION MADE: 22-OCT-07
SAN DIEGO, CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIUS SNARE
RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K070502(TRADITIONAL)
ATTN: RICHARD DEMELLO PHONE NO : 978-263-4466
15 CRAIG RD. SE DECISION MADE: 04-OCT-07
ACTON, MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDSENSE
REDSENSE MEDICAL AB 510(k) NO: K071013(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 18-OCT-07
FRIDLEY, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
REGENERATION TECHNOLOGIES, INC. 510(k) NO: K072327(SPECIAL)
ATTN: LISA SIMPSON PHONE NO : 386-418-8888
11621 RESEARCH CIR. SE DECISION MADE: 24-OCT-07
P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32616-2650
DEVICE: RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES
RELIANT TECHNOLOGIES, INC. 510(k) NO: K071621(TRADITIONAL)
ATTN: DAN MARINSIK PHONE NO : 650-605-2237
464 ELLIS ST. SE DECISION MADE: 09-OCT-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRACEPT BI-POLAR RF PROBE, MODEL 04814
RELIEVANT MEDSYSTEMS, INC. 510(k) NO: K070443(TRADITIONAL)
ATTN: MARK SMUTKA PHONE NO : 510-489-1080
713 SANDOVAL WAY SE DECISION MADE: 05-OCT-07
HAYWARD, CA 94544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAGE MICRO
RESMED LTD. 510(k) NO: K071808(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 10-OCT-07
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RNK ELECTRONIC STETHOSCOPE
RNK PRODUCTS, INC. 510(k) NO: K072026(TRADITIONAL)
ATTN: CHARLES R ABBRUSCATO PHONE NO : 612-414-0289
12700 DIAMOND DRIVE SE DECISION MADE: 26-OCT-07
BURNSVILLE, MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS CORTISOL TEST SYSTEM
ROCHE DIAGNOSTICS 510(k) NO: K070788(TRADITIONAL)
ATTN: KAY TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 05-OCT-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
ROCHE DIAGNOSTICS CORP. 510(k) NO: K072638(SPECIAL)
ATTN: KERWIN L KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 19-OCT-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVATOME, MODEL: SU101-50
SCHOLTEN SURGICAL INSTRUMENTS, INC510(k) NO: K072051(TRADITIONAL)
ATTN: JIM VAN ANDEL PHONE NO : 209-365-1393
170 COMMERCE ST. # 101 SE DECISION MADE: 03-OCT-07
LODI, CA 95240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZUMA
SEASPINE, INC. 510(k) NO: K071726(TRADITIONAL)
ATTN: ETHEL BERNAL PHONE NO : 760-727-8399
2302 LA MIRADA DR. SE DECISION MADE: 23-OCT-07
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANFAN POWDER-FREE VINYL EXAM GLOVES
SHANGHAI LANFAN CO., LTD. 510(k) NO: K072488(TRADITIONAL)
ATTN: BEI KAIFENG PHONE NO : 86 216 8865927
2002 HUAXIA BANK TOWER SE DECISION MADE: 19-OCT-07
256 PUDONG ROAD SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200120
DEVICE: PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K072235(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-OCT-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' )
SHIN CHANG MEDICAL CO., LTD. 510(k) NO: K071382(TRADITIONAL)
ATTN: JAN J FRANK PHONE NO : 801-263-0975
3762 SOUTH 150 EAST SE DECISION MADE: 16-OCT-07
SALT LAKE CITY, UT 84115 510(k) STATEMENT
DEVICE: VACU-MED BLOOD COLLECTION NEEDLES
SHINA CORP. 510(k) NO: K071947(TRADITIONAL)
ATTN: CAROLE STAMP PHONE NO : 952-746-8074
5353 WAYZATA BOULEVARD SE DECISION MADE: 12-OCT-07
SUITE 305 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55416-1334
DEVICE: 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K072909(TRADITIONAL)
ATTN: LUTZ MAHN PHONE NO : 499 131 842274
HENKESTRASSE 127 SE DECISION MADE: 31-OCT-07
ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DCA VANTAGE, MODEL 5075
SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K071466(SPECIAL)
ATTN: NOOR MALKI PHONE NO : 781-269-3401
2 EDGEWATER DR. SE DECISION MADE: 09-OCT-07
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K072204(ABBREVIATED)
ATTN: PHILIP LIU PHONE NO : 914-524-2443
511 BENEDICT AVENUE SE DECISION MADE: 05-OCT-07
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM VERIO
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K072237(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918
51 VALLEY STREAM PKWY. SE DECISION MADE: 10-OCT-07
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMBIA-E, MODEL 10275879
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K072567(SPECIAL)
ATTN: ALAINE MEDIO PHONE NO : 865-218-2703
2501 NORTH BARRINGTON RD. SE DECISION MADE: 30-OCT-07
HOFFMAN ESTATES, IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K072365(TRADITIONAL)
ATTN: ROBERT LAWRENCE PHONE NO : 650-943-5984
1230 SHOREBIRD WAY SE DECISION MADE: 17-OCT-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUASAR BLUE LIGHT THERAPY SYSTEM
SILVER BAY, LLC 510(k) NO: K072767(TRADITIONAL)
ATTN: GARY MOCNIK PHONE NO : 949-433-0413
24372 MCCLOUD COURT SE DECISION MADE: 15-OCT-07
LAGUNA NIGUEL, CA 92677 510(k) STATEMENT
DEVICE: REFLECTION, TANDEM UNIPOLAR
SMITH & NEPHEW, INC. 510(k) NO: K071160(TRADITIONAL)
ATTN: MEGAN BEVILL PHONE NO : 901-399-5340
1450 BROOKS RD. SE DECISION MADE: 05-OCT-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW ARTHROSCOPE
SMITH & NEPHEW, INC. 510(k) NO: K072675(SPECIAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
150 MINUTEMAN ROAD SE DECISION MADE: 15-OCT-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PNEUPAC VR1 AIR MIX
SMITHS MEDICAL INTERNATIONAL, LTD.510(k) NO: K071527(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON DRIVE SE DECISION MADE: 04-OCT-07
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPS AWAY DISPOSABLE CONTAINER
SOLUTIONS, INC. 510(k) NO: K072667(TRADITIONAL)
ATTN: JERRI ANDERSON PHONE NO : 502-228-2901
3600 CHAMBERLAIN LANE SE DECISION MADE: 10-OCT-07
SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA
LOUISVILLE, KY 40241 THIRD PARTY REVIEW
DEVICE: D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATE
SORIN GROUP ITALIA S.R.L. 510(k) NO: K072091(ABBREVIATED)
ATTN: BARRY SALL PHONE NO : 781-434-4742
200 WEST STREET SE DECISION MADE: 29-OCT-07
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUNMED COLOPOSCOPE COLPO-99/99PLUS
SOUNMED, INC. 510(k) NO: K070845(TRADITIONAL)
ATTN: RUBEN OLIVARES PHONE NO : 305-477-0986
6800 N.W. 77TH COURT SE DECISION MADE: 12-OCT-07
MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
SPECTRUM DYNAMICS LTD. 510(k) NO: K072468(SPECIAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
20 HATA'AS ST. SE DECISION MADE: 01-OCT-07
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSAIC DEVICES
SPINAL ELEMENTS, INC. 510(k) NO: K071833(TRADITIONAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 23-OCT-07
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCURY SPINAL SYSTEM
SPINAL ELEMENTS, INC. 510(k) NO: K071914(TRADITIONAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 12-OCT-07
CARLSBAD, CA 92008 510(k) STATEMENT
DEVICE: REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
STERILMED, INC. 510(k) NO: K070930(TRADITIONAL)
ATTN: DENNIS TOUSSAINT PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 18-OCT-07
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
STERIS CORPORATION 510(k) NO: K062297(TRADITIONAL)
ATTN: PATRICK J MCCULLAGH PHONE NO : 440-392-7601
5960 HEISLEY RD. SE DECISION MADE: 04-OCT-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIS-U-ALL II SELF SEAL POUCH
STERIS CORPORATION 510(k) NO: K070765(TRADITIONAL)
ATTN: PATRICK MCCULLAGH PHONE NO : 440-392-7601
5960 HEISLEY RD. SE DECISION MADE: 12-OCT-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VHP 136 TRAY
STERIS CORPORATION 510(k) NO: K070769(TRADITIONAL)
ATTN: PATRICK MCCULLAGH PHONE NO : 440-392-7601
5960 HEISLEY RD. SE DECISION MADE: 05-OCT-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
STERIS CORPORATION 510(k) NO: K071087(TRADITIONAL)
ATTN: JOHN R SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 16-OCT-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONY LED-1 SURGICAL LIGHTING SYSTEM
STERIS CORPORATION 510(k) NO: K072072(TRADITIONAL)
ATTN: JOHN SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 05-OCT-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
STRAUMANN USA 510(k) NO: K071888(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 15-OCT-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OASYS SYSTEM
STRYKER SPINE 510(k) NO: K072568(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 05-OCT-07
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
SUNRISE MEDICAL 510(k) NO: K071397(SPECIAL)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 814-443-7690
100 DEVILBISS DR. SE DECISION MADE: 01-OCT-07
SOMERSET, PA 15501 510(k) STATEMENT
DEVICE: GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODE
SYNCRO MEDICAL INNOVATIONS, INC. 510(k) NO: K072787(SPECIAL)
ATTN: WILLIAM MCLAIN PHONE NO : 717-656-9656
342 E MAIN STREET, SUITE 207 SE DECISION MADE: 31-OCT-07
LEOLA, PA 17540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES CHRONOS COMPOSITE
SYNTHES (USA) 510(k) NO: K071046(TRADITIONAL)
ATTN: JEFFREY DOW PHONE NO : 484-356-9720
1230 WILSON DRIVE SE DECISION MADE: 23-OCT-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNFIX-LR SPACER
SYNTHES SPINE CO.LP 510(k) NO: K072253(TRADITIONAL)
ATTN: SUSAN LEWANDOWSKI PHONE NO : 610-719-5712
1302 WRIGHTS LANE EAST SE DECISION MADE: 12-OCT-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-42
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K071493(TRADITIONAL)
ATTN: ERICA LI PHONE NO : 886 266 358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 26-OCT-07
SAN CHUNG,TAIPEI COUNTY R.O.C. 510(k) SUMMARY AVAILABLE FROM FDA
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 241
DEVICE: ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-42
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K072039(SPECIAL)
ATTN: ERICA LI PHONE NO : 886 2 66358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 03-OCT-07
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: ALPHARD CONE BEAM CT, MODEL X178
TAKARA BELMONT CORP. 510(k) NO: K072574(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 18-OCT-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES
TECHNOMED EUROPE 510(k) NO: K072016(TRADITIONAL)
ATTN: MAURICE ROOST PHONE NO : 314 340 86868
AMERIKALAAN 71 SE DECISION MADE: 19-OCT-07
MAASTRICHT AIRPORT, NETHERLANDS 61510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL,
THERMO ELECTRON OY 510(k) NO: K063131(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 329100
RATASTIE 2 SE DECISION MADE: 05-OCT-07
PO BOX 100 510(k) SUMMARY AVAILABLE FROM FDA
VANTAA, FINLAND FIN-01621
DEVICE: PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTR
THERMO ELECTRON OY 510(k) NO: K063145(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 329100
RATASTIE 2 SE DECISION MADE: 17-OCT-07
PO BOX 100 510(k) SUMMARY AVAILABLE FROM FDA
VANTAA, FINLAND FIN-01621
DEVICE: LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1,
THERMO ELECTRON OY 510(k) NO: K063705(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 329100
RATASTIE 2 SE DECISION MADE: 09-OCT-07
PO BOX 100 510(k) SUMMARY AVAILABLE FROM FDA
VANTAA, FINLAND FIN-01621
DEVICE: CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
THERMO FISHER SCIENTIFIC OY 510(k) NO: K071340(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 932 9100
2 RATASTIE SE DECISION MADE: 05-OCT-07
VANTAA, FINLAND 01620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
THERMO FISHER SCIENTIFIC OY 510(k) NO: K071580(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 329100
2 RATASTIE SE DECISION MADE: 03-OCT-07
VANTAA, FINLAND FIN-01621 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLONIC & ENEMA NOZZLE
TILLER MIND BODY, INC. 510(k) NO: K071057(TRADITIONAL)
ATTN: HAROLD L JONES PHONE NO : 210-236-3872
42 EAST WHISTERS BEND CIRCLE SE DECISION MADE: 05-OCT-07
THE WOODLANDS, TX 77384 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS REVERSED ADAPTER
TORNIER 510(k) NO: K071948(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898
161 RUE LAVOISIER SE DECISION MADE: 18-OCT-07
MONTBONNOT 510(k) SUMMARY AVAILABLE FROM FDA
SAINT-ISMIER CEDEX, FRANCE 38334
DEVICE: AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K072606(TRADITIONAL)
ATTN: PHONE NO :
2441 MICHELLE DR. SE DECISION MADE: 02-OCT-07
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CSCS-001A CALCIUM SCORING PACKAGE
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K072737(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 05-OCT-07
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K072826(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 24-OCT-07
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K072918(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DRIVE SE DECISION MADE: 29-OCT-07
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781 THIRD PARTY REVIEW
DEVICE: SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
TRANSNOMA MEDICAL, INC. 510(k) NO: K063035(TRADITIONAL)
ATTN: ANGELA RAUN PHONE NO : 651-481-7460
4358 WEST ROUND LAKE RD. SE DECISION MADE: 01-OCT-07
ARDEN HILLS, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKIN CARE LIGHT
TRANSVERSE INDUSTRIES CO. 510(k) NO: K070870(TRADITIONAL)
ATTN: HO K LIANG PHONE NO : 886 285 218692
NO. 305 HUA CHENG RD. SE DECISION MADE: 10-OCT-07
HSIN-CHUANG CITY, TAIPEI, CHINA (T510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
TYCO HEALTHCARE 510(k) NO: K071049(TRADITIONAL)
ATTN: WEI ZHAO PHONE NO : 508-261-8404
15 HAMPSHIRE ST. SE DECISION MADE: 16-OCT-07
MANSFIELD, MA 02048 510(k) STATEMENT
DEVICE: THROMBIX PATCH THROMBIN HEMOSTASIS PATCH
VASCULAR SOLUTIONS, INC. 510(k) NO: K072117(TRADITIONAL)
ATTN: JAMES CHAPMAN PHONE NO : 763-656-4380
6464 SYCAMORE COURT SE DECISION MADE: 05-OCT-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAX-D GENESIS G2 SYSTEM
VAX-D MEDICAL TECHNOLOGIES USA, L.510(k) NO: K071347(TRADITIONAL)
ATTN: LAWRENCE DYER PHONE NO : 813-343-5000
310 MEARS BLVD. SE DECISION MADE: 05-OCT-07
OLDSMAR, FL 34677 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MASTERSCREEN & OXYCON CPX
VIASYS HEALTHCARE GMBH 510(k) NO: K072323(SPECIAL)
ATTN: YVETTE LLOYD PHONE NO : 714-919-3247
22745 SAVI RANCH PKWY. SE DECISION MADE: 10-OCT-07
YORBA LINDA, CA 92887 510(k) STATEMENT
DEVICE: ONCONTROL BONE MARROW BIOPSY SYSTEM
VIDACARE CORPORATION 510(k) NO: K072045(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 22-OCT-07
IRVIN, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GATECT-RT
VISION RT LIMITED 510(k) NO: K072171(TRADITIONAL)
ATTN: ROBERT J MORTON, M.S. PHONE NO : 925-787-2421
1244 FAIRWAY VALLEY COURT SE DECISION MADE: 01-OCT-07
LINCOLN, CA 95648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONALIVE GRANULES AND BONALIVE PLATES
VIVOXID LTD. 510(k) NO: K071937(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 19-OCT-07
FRIDLEY, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL BONE WEDGE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K070592(TRADITIONAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701
5677 AIRLINE RD. SE DECISION MADE: 05-OCT-07
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K072597(TRADITIONAL)
ATTN: RYAN M BELANEY PHONE NO : 901-867-4778
5677 AIRLINE RD. SE DECISION MADE: 15-OCT-07
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
XUZHOU FULL SUN MEDICAL PRODUCTS L510(k) NO: K072401(ABBREVIATED)
ATTN: HSUN-HUI HUANG PHONE NO : 886 285 093976
BIHE INDUSTRY AREA SE DECISION MADE: 15-OCT-07
YITANG TOWN, PIZHOU COUNTY 510(k) SUMMARY AVAILABLE FROM FDA
JIANGSU, CHINA
DEVICE: DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
XUZHOU FULL SUN MEDICAL PRODUCTS L510(k) NO: K072472(ABBREVIATED)
ATTN: HSUN-HUI HUANG PHONE NO : 886 285 093976
BIHE INDUSTRY AREA SE DECISION MADE: 25-OCT-07
YITANG TOWN, PIZHOU COUNTY 510(k) SUMMARY AVAILABLE FROM FDA
JIANGSU, CHINA
DEVICE: QUIKCLOT EX
Z-MEDICA CORPORATION 510(k) NO: K072474(TRADITIONAL)
ATTN: RONALD E PETERSON PHONE NO : 203-294-0000
4 FAIRFIELD BLVD. SE DECISION MADE: 16-OCT-07
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX
Z-SYSTEMS AG 510(k) NO: K062542(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 29-OCT-07
STE: 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92024
DEVICE: TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13
ZIMMER DENTAL INC. 510(k) NO: K072589(SPECIAL)
ATTN: WILLIAM FISHER PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 04-OCT-07
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER DTO IMPLANT
ZIMMER SPINE, INC 510(k) NO: K071879(TRADITIONAL)
ATTN: NICOLE BOWDEN PHONE NO : 952-857-5643
7375 BUSH LAKE RD. SE DECISION MADE: 05-OCT-07
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMA ZS TRANSITION SCREW, MODELS SDA7030, 7055, SD4030-8055
ZIMMER SPINE, INC 510(k) NO: K071880(TRADITIONAL)
ATTN: NICOLE BOWDEN PHONE NO : 952-857-5643
7375 BUSH LAKE RD. SE DECISION MADE: 05-OCT-07
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-800 VOLUMETRIC INFUSION PUMP
ZYNO MEDICAL LLC 510(k) NO: K071545(TRADITIONAL)
ATTN: CHAOYOUNG LEE PHONE NO : 781-895-1988
395 TOTTEN POND RD. SUITE 201 SE DECISION MADE: 31-OCT-07
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 265
TOTAL WITH SUMMARIES 244
TOTAL WITH STATEMENTS 21
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