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
Updated November 5, 2007
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