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510(k)s Final Decisions Rendered for November 2004 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-NOV-2004 THROUGH 30-NOV-2004 DEVICE: 3M TEGADERM SILVER 3M COMPANY 510(k) NO: K040890(TRADITIONAL) ATTN: AMY E SHORT PHONE NO : 651-737-6707 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 02-NOV-04 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3VISEON 3MENSIO MEDICAL IMAGING BV 510(k) NO: K043097(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 19-NOV-04 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ETEST FOR GEMIFLOXACIN AB BIODISK 510(k) NO: K042390(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760 DALVAGEN 10 SE DECISION MADE: 19-NOV-04 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: ACCUPACH V ACCUTOME ULTRASOUND, INC. 510(k) NO: K042752(TRADITIONAL) ATTN: JEFFREY L WRIGHT PHONE NO : 610-889-0200 263 GREAT VALLEY PARKWAY SE DECISION MADE: 10-NOV-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM ACMI CORPORATION 510(k) NO: K042069(TRADITIONAL) ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2739 136 TURNPIKE RD. SE DECISION MADE: 01-NOV-04 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETSTREAM WORKSPACE ADAC LABORATORIES 510(k) NO: K042880(TRADITIONAL) ATTN: COLEEN A COLEMAN PHONE NO : 408-468-3051 540 ALDER DR. SE DECISION MADE: 03-NOV-04 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADEPT ULTRALITE 532 LASER ADEPT MEDICAL CONCEPTS, INC. 510(k) NO: K042496(TRADITIONAL) ATTN: JERRY MCFARLAND PHONE NO : 949-635-9238 29866 AVENIDA DE LAS BANDERAS SE DECISION MADE: 02-NOV-04 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S AEARO CO. 510(k) NO: K041855(ABBREVIATED) ATTN: ANN PHILLIPS PHONE NO : 508-764-5713 90 MECHANIC ST. SE DECISION MADE: 10-NOV-04 SOUTHBRIDGE, MA 01550 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INSTANT-VIEW TROPONIN I TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K042227(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 858-513-3888 12330 STOWE DR. SE DECISION MADE: 19-NOV-04 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED DIAMOND BURS ALLIANCE MEDICAL CORP. 510(k) NO: K041978(TRADITIONAL) ATTN: ERIC VARTY PHONE NO : 480-763-5335 10232 SOUTH 51ST ST. SE DECISION MADE: 23-NOV-04 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM ALOKA CO., LTD. 510(k) NO: K043196(TRADITIONAL) ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-5088 10 FAIRFIELD BLVD. SE DECISION MADE: 30-NOV-04 WALLINGFORD, CT 06492-7502 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SENSATOUCH ALUNA MANAGEMENT CO., LTD. 510(k) NO: K042250(TRADITIONAL) ATTN: CHARITY MARTIN PHONE NO : 877-353-8378 4859 MARTIN CT. SE DECISION MADE: 12-NOV-04 SUITE #5 510(k) SUMMARY AVAILABLE FROM FDA SMYRNA, GA 30082 DEVICE: AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR AMBU, INC. 510(k) NO: K042682(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410-636-1144 611 NORTH HAMMONDS FERRY ROAD SE DECISION MADE: 15-NOV-04 LINTHICUM, MD 21090-1356 510(k) STATEMENT DEVICE: AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATO AMBU, INC. 510(k) NO: K042843(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410-636-1144 611 NORTH HAMMONDS FERRY ROAD SE DECISION MADE: 12-NOV-04 LINTHICUM, MD 21090-1356 510(k) STATEMENT DEVICE: 'RAPIDTEC 4' TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K041712(TRADITIONAL) ATTN: HENRY WELLS PHONE NO : 410-992-4734 9110 RED BRANCH ROAD SE DECISION MADE: 03-NOV-04 SUITE B 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21045 DEVICE: MB SYSTEM, BIOENERGY LIGHT THERAPY AMEST CORP. 510(k) NO: K030275(TRADITIONAL) ATTN: JOHN IEST PHONE NO : 949-766-9692 30394 ESPERANZA SE DECISION MADE: 29-NOV-04 SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAMOMETER - MODEL FCE AND MODEL MSC AMETEK 510(k) NO: K042889(TRADITIONAL) ATTN: PHILIP LACHANCE PHONE NO : 727-536-7831 8600 SOMERSET DR. SE DECISION MADE: 16-NOV-04 LARGO, FL 33773 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 AMPLIFE CORPORATION 510(k) NO: K042906(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-NOV-04 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 ANALOGIC CORP. 510(k) NO: K043025(ABBREVIATED) ATTN: DONALD J SHERRATT PHONE NO : 978-977-3000 8 CENTENNIAL DR. SE DECISION MADE: 19-NOV-04 CENTENNIAL INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA PEABODY, MA 01960 DEVICE: METRICATH SYSTEM ANGIOMETRX INC. 510(k) NO: K042685(TRADITIONAL) ATTN: TIM VERSPAGEN PHONE NO : 604 742 3810 1099 8TH AVENUE WEST SE DECISION MADE: 18-NOV-04 UNIT 107 510(k) SUMMARY AVAILABLE FROM FDA VANCOUVER, BC, CANADA V6H 1C3 DEVICE: EZY-TRAVEL WRISTBAND APOTHECARY PRODUCTS, INC. 510(k) NO: K041766(TRADITIONAL) ATTN: DAVID KRAMER PHONE NO : 952-808-8324 11750 12TH AVE. SOUTH SE DECISION MADE: 26-NOV-04 BURNSVILLE, MN 55337-1295 510(k) STATEMENT DEVICE: THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS ARKRAY, INC. 510(k) NO: K041427(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 206-262-7363 510 FURNACE DOCK RD. SE DECISION MADE: 24-NOV-04 CORTLANDT MANOR, NY 10567 510(k) STATEMENT DEVICE: SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS A ARKRAY, INC. 510(k) NO: K042443(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 206-262-7363 510 FURNACE DOCK RD. SE DECISION MADE: 24-NOV-04 CORTLANDT MANOR, NY 10567 510(k) STATEMENT DEVICE: ARTHREX TRIMIT FAMILY ARTHREX, INC. 510(k) NO: K041189(TRADITIONAL) ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 04-NOV-04 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX TENODESIS SCREW FAMILY ARTHREX, INC. 510(k) NO: K041356(TRADITIONAL) ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 04-NOV-04 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MCL 30 DERMABLATE ER:YAG LASER SYSTEM ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K042968(SPECIAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DRIVE SE DECISION MADE: 24-NOV-04 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 ATOS MEDICAL AB 510(k) NO: K043138(SPECIAL) ATTN: EDDY ABERG PHONE NO : 46 415 19800 KRAFTGATAN 8 SE DECISION MADE: 22-NOV-04 HORBY, SWEDEN SE-242 22 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIDI BRAND STERILIZATION WRAP BANTA HEALTHCARE GROUP, LTD. 510(k) NO: K042580(TRADITIONAL) ATTN: INA GORDON PHONE NO : 727-797-4727 2454 MCMULLEN BOOTH RD. SE DECISION MADE: 17-NOV-04 CLEARWATER, FL 33759 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW 510(k) NO: K042660(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 505-332-8445 12200 ACADEMY ROAD NE SE DECISION MADE: 19-NOV-04 # 931 510(k) SUMMARY AVAILABLE FROM FDA ALBUQUERQUE, NM 87111 DEVICE: NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW 510(k) NO: K042661(TRADITIONAL) ATTN: FRANK FURGUSON PHONE NO : 505-332-8445 12200 ACADEMY ROAD NE SE DECISION MADE: 19-NOV-04 # 931 510(k) SUMMARY AVAILABLE FROM FDA ALBUQUERQUE, NM 87111 DEVICE: NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW 510(k) NO: K042662(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 505-332-8445 12200 ACADEMY ROAD NE SE DECISION MADE: 22-NOV-04 # 931 510(k) SUMMARY AVAILABLE FROM FDA ALBUQUERQUE, NM 87111 DEVICE: MGP 15 DICOM THEATER BARCO NV BARCOVIEW 510(k) NO: K042942(TRADITIONAL) ATTN: FRANK FURGUSON PHONE NO : 505-332-8445 12200 ACADEMY ROAD NE SE DECISION MADE: 22-NOV-04 # 931 510(k) SUMMARY AVAILABLE FROM FDA ALBUQUERQUE, NM 87111 DEVICE: BASBA E-MACHINE BASBA INC. 510(k) NO: K041172(TRADITIONAL) ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433 12101 CULLEN BLVD, #A SE DECISION MADE: 18-NOV-04 HOUSTON, TX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PUMP CONNECTIVITY INTERFACE BAXTER HEALTHCARE CORP. 510(k) NO: K040985(TRADITIONAL) ATTN: JENNIFER M PAINE PHONE NO : 847-270-5825 ONE BAXTER PKWY. SE DECISION MADE: 30-NOV-04 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE BAXTER HEALTHCARE CORP. 510(k) NO: K042936(TRADITIONAL) ATTN: NANETTE HEDDEN PHONE NO : 847-473-6281 ROUTE 120 AND WILSON RD. SE DECISION MADE: 26-NOV-04 ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS BECKMAN COULTER, INC. 510(k) NO: K042291(TRADITIONAL) ATTN: MARY BETH TANG PHONE NO : 714-961-3777 200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 12-NOV-04 P.O. BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA BREA, CA 92822-8000 DEVICE: SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT BECKMAN COULTER, INC. 510(k) NO: K042459(TRADITIONAL) ATTN: KIM WALKER PHONE NO : 714-961-4912 200 SOUTH KRAEMER BLVD. SE DECISION MADE: 17-NOV-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER BECTON DICKINSON & CO. 510(k) NO: K042491(TRADITIONAL) ATTN: LESLIE WOOD PHONE NO : 801-565-2504 9450 SOUTH STATE STREET SE DECISION MADE: 22-NOV-04 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BBLCHROMAGAR MRSA BECTON DICKINSON & CO. 510(k) NO: K042812(TRADITIONAL) ATTN: DENNIS R MERTZ PHONE NO : 410-316-4099 7 LOVETON CIR. SE DECISION MADE: 22-NOV-04 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MUCOTROL CONCENTRATED ORAL GEL WAFER BELCHER PHARMACEUTICALS, INC. 510(k) NO: K042400(TRADITIONAL) ATTN: KOTHA SEKHARAM PHONE NO : 727-530-9751 12393 BELCHER ROAD SE DECISION MADE: 24-NOV-04 SUITE 420 510(k) SUMMARY AVAILABLE FROM FDA LARGO, FL 33773 DEVICE: BEST BREAST BRACHYTHERAPY APPLICATOR BEST MEDICAL INTERNATIONAL, INC. 510(k) NO: K042586(TRADITIONAL) ATTN: JOSEPH C WANG PHONE NO : 800-336-4970 7643 FULLERTON RD. SE DECISION MADE: 03-NOV-04 SPRINGFIELD, VA 22153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEST MODEL # 81-01 SERIES IR-192 SOURCES BEST MEDICAL INTERNATIONAL, INC. 510(k) NO: K042786(ABBREVIATED) ATTN: JOSEPH C WANG PHONE NO : 800-336-4970 7643 FULLERTON RD. SE DECISION MADE: 18-NOV-04 SPRINGFIELD, VA 22153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BICONITE SURFACE TREATMENT BICON, INC. 510(k) NO: K031568(TRADITIONAL) ATTN: VINCENT J MORGAN PHONE NO : 617-390-4363 501 ARBOWAY SE DECISION MADE: 23-NOV-04 BOSTON, MA 02130 510(k) STATEMENT DEVICE: THE 5.0 X 6.0MM DENTAL IMPLANT BICON, INC. 510(k) NO: K042637(TRADITIONAL) ATTN: VINCENT J MORGAN PHONE NO : 617-390-4363 501 ARBOWAY SE DECISION MADE: 15-NOV-04 BOSTON, MA 02130 510(k) STATEMENT DEVICE: QUEST TUMOR MARKER CONTROL, MODEL 955 BIO-RAD 510(k) NO: K042815(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 05-NOV-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK RETICULOCYTE CONTROL (A) BIO-RAD 510(k) NO: K042836(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 05-NOV-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ELEVATED CRP CONTROL BIO-RAD 510(k) NO: K042837(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 02-NOV-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) BIO-RAD 510(k) NO: K042865(TRADITIONAL) ATTN: SUZANNE S PARSONS PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 24-NOV-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS BIO-RAD LABORATORIES, INC. 510(k) NO: K042446(TRADITIONAL) ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367 9500 JERONIMO RD. SE DECISION MADE: 02-NOV-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED 510(k) NO: K042231(TRADITIONAL) ATTN: JOHN GREENBAUM PHONE NO : 954-680-0161 20310 SW 48TH STREET SE DECISION MADE: 12-NOV-04 FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT BIOFILM, INC. 510(k) NO: K041432(TRADITIONAL) ATTN: ROBERT L DE ARMOND PHONE NO : 760-727-9030 3225 EXECUTIVE RIDGE SE DECISION MADE: 30-NOV-04 VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE BIOGEN 510(k) NO: K042314(TRADITIONAL) ATTN: VICTOR J GANGI PHONE NO : 617-679-6238 14 CAMBRIDGE CENTER SE DECISION MADE: 22-NOV-04 CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENT BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K041388(TRADITIONAL) ATTN: GARY BUSSETT PHONE NO : 760-727-5600 2448 CADES WAY SE DECISION MADE: 23-NOV-04 P.O. BOX 1360 510(k) STATEMENT VISTA, CA 92085-1360 DEVICE: X-SERIES INTEGRAL RPP FEMORAL COMPONENTS BIOMET, INC. 510(k) NO: K042029(SPECIAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 09-NOV-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS BIOMET, INC. 510(k) NO: K042093(TRADITIONAL) ATTN: TAACY BICKEL JOHNSON PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 01-NOV-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818 BIOPRO, INC. 510(k) NO: K041595(TRADITIONAL) ATTN: DAVID MARK PHONE NO : 810-982-7777 17 SEVENTEENTH ST. SE DECISION MADE: 12-NOV-04 PORT HURON, MI 48060 510(k) STATEMENT DEVICE: TRIAGE D-DIMER TEST, MODEL 98100 BIOSITE INCORPORATED 510(k) NO: K042890(TRADITIONAL) ATTN: JEFFERY R DAHLEN PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 29-NOV-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VISITOME 20-10 MICROKERATOME BIOVISION AG 510(k) NO: K042083(TRADITIONAL) ATTN: DALE SADLIK PHONE NO : 949-450-0770 27 MAUCHLY, UNIT 206 SE DECISION MADE: 16-NOV-04 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSATILE 1 WOUND VACUUM SYSTEM BLUE SKY MEDICAL GROUP INCORPORATE510(k) NO: K042134(TRADITIONAL) ATTN: RICHARD WESTON PHONE NO : 760-727-1477 1485 POINSETTIA AVE., STE 118 SE DECISION MADE: 01-NOV-04 VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/ BOSTON SCIENTIFIC CORP. 510(k) NO: K041818(SPECIAL) ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307 47900 BAYSIDE PARKWAY SE DECISION MADE: 10-NOV-04 FREMONT, CA 94538-6515 510(k) STATEMENT DEVICE: ENTERYX INJECTION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K042882(SPECIAL) ATTN: LISA M QUAGLIA PHONE NO : 508-650-8267 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 09-NOV-04 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER BUSSE HOSPITAL DISPOSABLES 510(k) NO: K041464(TRADITIONAL) ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711 PO BOX 11067 SE DECISION MADE: 05-NOV-04 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIFUSION, MODEL 0609190/0659350 C.R. BARD, INC. 510(k) NO: K041088(ABBREVIATED) ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 01-NOV-04 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE T C.R. BARD, INC. 510(k) NO: K042949(TRADITIONAL) ATTN: JOHN C KNORPP PHONE NO : 770-784-6451 8195 INDUSTRIAL BLVD. SE DECISION MADE: 09-NOV-04 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR CADWELL LABORATORIES, INC. 510(k) NO: K042350(TRADITIONAL) ATTN: CHRIS BOLKAN PHONE NO : 509-735-6481 909 NORTH KELLOGG ST. SE DECISION MADE: 03-NOV-04 KENNEWICK, WA 99336 510(k) STATEMENT DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. 510(k) NO: K041242(TRADITIONAL) ATTN: LORRAINE CALZETTA PATROVIC PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 22-NOV-04 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODE CAO GROUP, INC. 510(k) NO: K041392(TRADITIONAL) ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282 8683 SOUTH 700 WEST SE DECISION MADE: 08-NOV-04 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K042615(TRADITIONAL) ATTN: ROBERT W JOHNSON PHONE NO : 651-762-2146 1290 HAMMOND RD. SE DECISION MADE: 05-NOV-04 ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMMANDER II CARDIOCOM 510(k) NO: K043096(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976 6740 RIVERVIEW TERRACE SE DECISION MADE: 24-NOV-04 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QUADRANT UNIT-1-BOND CAVEX HOLLAND B.V. 510(k) NO: K042806(TRADITIONAL) ATTN: RICHARD WOORTMAN PHONE NO : 312 353 07763 HARMENJANSWEG 19-21 SE DECISION MADE: 24-NOV-04 P.O. BOX 852 510(k) STATEMENT HAARLEM (HOLLAND), NETHERLANDS 2003 RW DEVICE: NICOM CHEETAH MEDICAL LTD. 510(k) NO: K042144(TRADITIONAL) ATTN: BENNY ARAZY PHONE NO : 972 4 9940337 MIZPE AVIV, INDUSTRIAL PARK 13 SE DECISION MADE: 12-NOV-04 M.P. MISGAV, ISRAEL 20187 510(k) STATEMENT DEVICE: AQUIFY LENS COMFORT DROPS CIBA VISION CORPORATION 510(k) NO: K042176(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897 11460 JOHNS CREEK PARKWAY SE DECISION MADE: 03-NOV-04 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 CLEVELAND MEDICAL DEVICES, INC. 510(k) NO: K042039(TRADITIONAL) ATTN: ROBERT N SCHMIDT PHONE NO : 216-791-6720 4415 EUCLID AVE SE DECISION MADE: 17-NOV-04 CLEVELAND, OH 44103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE COAPT SYSTEMS, INC. 510(k) NO: K042796(SPECIAL) ATTN: BANKIM MEHTA PHONE NO : 650-461-7600 1820 EMBARCADERO RD. SE DECISION MADE: 05-NOV-04 PALO ALTO, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM COBE CARDIOVASCULAR, INC. 510(k) NO: K042473(ABBREVIATED) ATTN: JACK ELLISON PHONE NO : 303-467-6306 14401 WEST 65TH WAY SE DECISION MADE: 19-NOV-04 ARVADA, CO 80004-3599 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PET-DOSE COMECER S.R.L. 510(k) NO: K042746(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 22-NOV-04 CROFTON, MD 21114 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE COOK, INC. 510(k) NO: K042611(SPECIAL) ATTN: EARL KNIGHT PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 12-NOV-04 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTAC COOPERVISION, INC. 510(k) NO: K042824(TRADITIONAL) ATTN: BONNIE J TSYMBAL PHONE NO : 585-264-3210 711 NORTH RD. SE DECISION MADE: 16-NOV-04 SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY CORDIS CORP. 510(k) NO: K042969(SPECIAL) ATTN: DONNA MARSHALL PHONE NO : 908-412-3844 7 POWDER HORN DR. SE DECISION MADE: 08-NOV-04 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHIGENE HEP-ANA TEST SYSTEM CORGENIX, INC. 510(k) NO: K042680(TRADITIONAL) ATTN: YUSUKE KOBE PHONE NO : 847-375-9091 455 STATE STREET SE DECISION MADE: 19-NOV-04 DES PLAINES, IL 60016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM CRYOVASCULAR SYSTEMS, INC. 510(k) NO: K042230(TRADITIONAL) ATTN: KIM TOMPKINS PHONE NO : 408-866-3203 160 KNOWLES DR. SE DECISION MADE: 05-NOV-04 LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL DRAPE KIT - D.I.R.R.A. SRL D.I.R.R.A. S.R.L. 510(k) NO: K041080(TRADITIONAL) ATTN: ELISABETTA BACCHI PHONE NO : 39 037 5785829 26, VIA GUIDO ROSSA SE DECISION MADE: 30-NOV-04 (Z.I. GERBOLINA) 510(k) SUMMARY AVAILABLE FROM FDA VIADANA, MANTOVA, ITALY I - 46019 DEVICE: MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHO DADE BEHRING, INC. 510(k) NO: K042347(TRADITIONAL) ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798 BLDG. 500 MAIL BOX 514 SE DECISION MADE: 19-NOV-04 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: ORAJEL ADVANCED TOOTH DESENSITIZER DEL PHARMACEUTICALS, INC. 510(k) NO: K041680(TRADITIONAL) ATTN: MARLENE TIETJEN PHONE NO : 516-844-2925 178 EAB PLAZA, PO BX 9357 SE DECISION MADE: 10-NOV-04 UNIONDALE, NY 11553-9357 510(k) STATEMENT DEVICE: SAVEDENT BLUE DENFOTEX LIGHT SYSTEMS LTD 510(k) NO: K042196(TRADITIONAL) ATTN: JOHN COLLES PHONE NO : 441 383 411555 UNIT 15, BELLEKNOWES IND.EST SE DECISION MADE: 01-NOV-04 INVERKEITHING FIFE, SCOTLAND, UNIT510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SOUTH BEACH SMILE LIGHT WHITENING SYSTEM DENTOVATIONS, INC. 510(k) NO: K042153(TRADITIONAL) ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433 12101 CULLEN BLVD. SE DECISION MADE: 08-NOV-04 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA HOUSTON, TX 77047 DEVICE: NEO-CLIP ORTHODONTIC BRACKET ACCESSORY DENTSPLY INTL. 510(k) NO: K042905(SPECIAL) ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 04-NOV-04 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: SPIRALOK ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K041069(TRADITIONAL) ATTN: KAREN SYLVIA PHONE NO : 781-251-2704 249 VANDERBILT AVE. SE DECISION MADE: 09-NOV-04 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTIN RC ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K041075(TRADITIONAL) ATTN: KAREN SYLVIA PHONE NO : 781-251-2704 249 VANDERBILT DR. SE DECISION MADE: 09-NOV-04 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. 510(k) NO: K042544(TRADITIONAL) ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867 325 PARAMOUNT DR. SE DECISION MADE: 23-NOV-04 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K041926(TRADITIONAL) ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396 16 MCCARVILLE ST. SE DECISION MADE: 23-NOV-04 CHARLOTTETOWN, PE, CANADA C1E 2A6 510(k) STATEMENT DEVICE: LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K041927(TRADITIONAL) ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396 16 MCCARVILLE ST. SE DECISION MADE: 23-NOV-04 CHARLOTTETOWN, PE, CANADA C1E 2A6 510(k) STATEMENT DEVICE: HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K041928(TRADITIONAL) ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396 16 MCCARVILLE ST. SE DECISION MADE: 23-NOV-04 CHARLOTTETOWN, PE, CANADA C1E 2A6 510(k) STATEMENT DEVICE: PRIMUS US DRAEGER MEDICAL, INC. 510(k) NO: K042607(TRADITIONAL) ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400 3135 QUARRY RD. SE DECISION MADE: 26-NOV-04 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE ED. GEISTLICH SOEHNE AG FUER CHEMI510(k) NO: K042197(TRADITIONAL) ATTN: PETER S REICHERTZ PHONE NO : 202-408-9222 1301 K STREET NW SE DECISION MADE: 15-NOV-04 SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: REUSABLE FINGER CLIP SPO2 SENSORS ELEKON INDUSTRIES U.S.A., INC. 510(k) NO: K042704(TRADITIONAL) ATTN: KRISTA OAKES PHONE NO : 972-849-5167 2300 MCDERMOTT RD. SE DECISION MADE: 26-NOV-04 #200-207 510(k) SUMMARY AVAILABLE FROM FDA PLANO, TX 75025 DEVICE: METAL/METAL HIP SYSTEM ENCORE MEDICAL, L.P. 510(k) NO: K040354(SPECIAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 04-NOV-04 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 ENDO OPTIKS, INC. 510(k) NO: K042918(SPECIAL) ATTN: KEITH HERTZ PHONE NO : 732-530-6762 39 SYCAMORE AVE. SE DECISION MADE: 22-NOV-04 LITTLE SILVER, NJ 07739-1208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENPATH SAFETY INTRODUCER ENPATH MEDICAL INCORPORATED 510(k) NO: K041708(TRADITIONAL) ATTN: KARYL HASKELL PHONE NO : 763-577-2257 15301 HWY. 55 WEST SE DECISION MADE: 30-NOV-04 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGE MEDICAL ACQUISITION STATION (IMAS) ERAD IMAGEMEDICAL CORP. 510(k) NO: K042700(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 08-NOV-04 SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMOTOME MR BIOPSY SYSTEM ETHICON ENDO-SURGERY, INC. 510(k) NO: K042753(TRADITIONAL) ATTN: CAROL J SPRINKLE PHONE NO : 513-337-3792 4545 CREEK RD. SE DECISION MADE: 08-NOV-04 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE ETHICON ENDO-SURGERY, INC. 510(k) NO: K042897(TRADITIONAL) ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146 4545 CREEK RD. SE DECISION MADE: 19-NOV-04 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVATION 12/14 PRESS-FIT FEMORAL STEM EXACTECH, INC. 510(k) NO: K042842(SPECIAL) ATTN: LISA SIMPSON PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 09-NOV-04 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELF RETAINING BICANALICULUS INTUBATION SET FCI OPHTHALMICS, INC. 510(k) NO: K041869(TRADITIONAL) ATTN: LOUIS ARMAND PHONE NO : 000-000-0000 P.O. BOX 465 SE DECISION MADE: 18-NOV-04 76 PROSPECT ST. 510(k) STATEMENT MARSHFIELD HILLS, MA 02051 DEVICE: MORTON IUI CATHETERS FERTILITY TECHNOLOGY RESOURCES, IN510(k) NO: K041470(TRADITIONAL) ATTN: CONSTANCE W STURGEON PHONE NO : 770-641-9487 4343 SHALLOWFORD RD. SE DECISION MADE: 22-NOV-04 SUITE D-4 510(k) STATEMENT MARIETTA, GA 30062 DEVICE: ALUMINA HEAD FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K042035(TRADITIONAL) ATTN: CHRISTINE QUENDEZ PHONE NO : 33 2 98556895 ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 17-NOV-04 QUIMPER, FRANCE 29000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 FUJINON, INC. 510(k) NO: K041903(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 543 LONG HILL AVENUE SE DECISION MADE: 10-NOV-04 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 FUJINON, INC. 510(k) NO: K042043(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 24-NOV-04 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 FUJINON, INC. 510(k) NO: K042076(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 18-NOV-04 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT CA 125 II ASSAY FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K042731(TRADITIONAL) ATTN: KIMBERLY PETERSON PHONE NO : 610-240-3828 201 GREAT VALLEY PKWY. SE DECISION MADE: 19-NOV-04 MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A GAMBRO RENAL PRODUCTS 510(k) NO: K040301(TRADITIONAL) ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094 10810 WEST COLLINS AVE. SE DECISION MADE: 01-NOV-04 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRADIA DIRECT LOFLO GC AMERICA, INC. 510(k) NO: K042348(TRADITIONAL) ATTN: TERRY JORITZ PHONE NO : 708-597-0900 3737 WEST 127TH ST. SE DECISION MADE: 18-NOV-04 ALSIP, IL 60803 510(k) STATEMENT DEVICE: AMX5 AND AMX5D MOBILE X-RAY SYSTEMS GE HEALTHCARE TECHNOLOGIES 510(k) NO: K042866(TRADITIONAL) ATTN: D. DUERSTELER PHONE NO : 262-312-7029 P.O. BOX 414 SE DECISION MADE: 02-NOV-04 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADVANCED LUNG ANALYSIS II GE MEDICAL SYSTEMS 510(k) NO: K042694(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 18-NOV-04 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRA GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K042642(TRADITIONAL) ATTN: ANDREW KLUESSENDORF PHONE NO : 414-362-3063 8200 WEST TOWER AVE. SE DECISION MADE: 03-NOV-04 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA GE MEDICAL SYSTEMS, INC. 510(k) NO: K042844(SPECIAL) ATTN: LARRY KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 03-NOV-04 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM-TWIN TENS/ MODELS GM3XY/Z GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K042559(SPECIAL) ATTN: BODEN S.P. LAI PHONE NO : 886 288 091799 11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 17-NOV-04 CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN) 251 DEVICE: GENEMAX POWER WHEELCHAIR, PW3 GENEMAX MEDICAL PRODUCTS INDUSTRY 510(k) NO: K042748(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5209783 NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-NOV-04 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENEMAX POWER WHEELCHAIR, PW4 GENEMAX MEDICAL PRODUCTS INDUSTRY 510(k) NO: K042749(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-NOV-04 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM GENERAL ELECTRIC CO. 510(k) NO: K043112(SPECIAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 24-NOV-04 W-400 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53201 DEVICE: GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTO GENESIS MEDICAL TECHNOLOGY, INC. 510(k) NO: K041239(TRADITIONAL) ATTN: THOMAS KROENKE PHONE NO : 303-956-4232 1555 EAST FLAMINGO ROAD SE DECISION MADE: 08-NOV-04 SUITE 155 510(k) SUMMARY AVAILABLE FROM FDA LAS VEGAS, NV 89119 DEVICE: GENICON SUCTION IRRIGATION SYSTEM GENICON 510(k) NO: K041967(ABBREVIATED) ATTN: GARY HABERLAND PHONE NO : 321-297-1189 427 LAKE HOWELL SE DECISION MADE: 12-NOV-04 MAITLAND, FL 32751 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENICON BIPOLAR FORCEPS MODEL # 600-005-005 GENICON 510(k) NO: K041968(ABBREVIATED) ATTN: GARY HABERLAND PHONE NO : 427 LAKE HOWELL SE DECISION MADE: 03-NOV-04 MAITLAND, FL 32751 510(k) STATEMENT DEVICE: GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO GIVEN IMAGING LTD. 510(k) NO: K042960(SPECIAL) ATTN: SHOSH FRIEDMAN PHONE NO : 972 4 9097784 13 HAYETZIRA STREET SE DECISION MADE: 24-NOV-04 NEW INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM, ISRAEL 20692 DEVICE: MODIFICATION TO PROTEX STABILIZATION SYSTEM GLOBUS MEDICAL, INC. 510(k) NO: K042953(SPECIAL) ATTN: KELLY J BAKER PHONE NO : 610-415-9000 303 SCHELL LANE SE DECISION MADE: 22-NOV-04 PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K042830(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 714-990-6488 590 W. CENTRAL AVE., #D SE DECISION MADE: 17-NOV-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS GUANGZHOU FORTUNIQUE LTD. 510(k) NO: K041501(TRADITIONAL) ATTN: JANE B CAMPBELL PHONE NO : 845-469-4289 485 LAROE ROAD SE DECISION MADE: 30-NOV-04 CHESTER, NY 10918 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM GUIDANT CORP. 510(k) NO: K042908(SPECIAL) ATTN: VIRGINIA SINGER PHONE NO : 408-845-2233 3200 LAKESIDE DR. SE DECISION MADE: 12-NOV-04 SANTA CLARA, CA 95054-2807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERICHEK GLUTARALDEHYDE REAGENT STRIPS HACH COMPANY 510(k) NO: K040660(TRADITIONAL) ATTN: DAVID A MORRIS PHONE NO : 219-262-2060 23575 COUNTY ROAD 106 SE DECISION MADE: 15-NOV-04 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL HEALTH & LIFE CO., LTD. 510(k) NO: K042853(SPECIAL) ATTN: PAUL HUNG PHONE NO : 886 2 82271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 10-NOV-04 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SO HOSPIRA, INC. 510(k) NO: K042980(SPECIAL) ATTN: PATRICIA MELERSKI PHONE NO : 224-212-4880 275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 17-NOV-04 D-389 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, IL 60045-5045 DEVICE: SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT HOWMEDICA OSTEONICS CORP 510(k) NO: K042883(SPECIAL) ATTN: DENISE DUCHENE PHONE NO : 201-831-5612 325 CORPORATE DR. SE DECISION MADE: 23-NOV-04 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS HOWMEDICA OSTEONICS CORP. 510(k) NO: K041170(TRADITIONAL) ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 325 CORPORATE DRIVE SE DECISION MADE: 09-NOV-04 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IOP8 INTRA OPERATIVE PROBE HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K032315(TRADITIONAL) ATTN: B.J. COLLEYPRIEST PHONE NO : 800-223-1218 35 PORTMANMOOR ROAD SE DECISION MADE: 18-NOV-04 CARDIFF, UNITED KINGDOM CF24 5HN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLENIUM, MODELS 2000, 2001 AND 2002 HYPERBARIC FOR LIFE LLC 510(k) NO: K041007(TRADITIONAL) ATTN: RICK RYDER PHONE NO : 602-973-1776 3206 WEST STATE AVE. SE DECISION MADE: 15-NOV-04 PHOENIX, AZ 85051 510(k) STATEMENT DEVICE: SECOND LOOK VIEWER ICAD INC. 510(k) NO: K042697(TRADITIONAL) ATTN: JOHN ROSENSTENGEL PHONE NO : 937-431-7978 2689 COMMONS BLVD., SUITE 100 SE DECISION MADE: 19-NOV-04 BEAVERCREEK, OH 45431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMALUX NIRIS IMAGING SYSTEM IMALUX CORPORATION 510(k) NO: K042894(SPECIAL) ATTN: STEPHANIE HARRINGTON PHONE NO : 216-502-0755 1771 EAST 30TH STREET SE DECISION MADE: 19-NOV-04 CLEVELAND, OH 44114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WEST NILE DETECT IGM ELISA INBIOS INTL., INC. 510(k) NO: K041817(TRADITIONAL) ATTN: ESTELA I RAYCHAUDHURI PHONE NO : 206-344-5821 562 1ST. AVE. SOUTH, SUITE 600 SE DECISION MADE: 19-NOV-04 SEATTLE, WA 98104 510(k) STATEMENT DEVICE: INNOJECT AUTO-INJECTOR INNOJECT, INC 510(k) NO: K042557(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5600 555 THIRTEENTH STREET, NW SE DECISION MADE: 08-NOV-04 WASHINGTON, DC 20004-5600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM INTERPORE CROSS INTL. 510(k) NO: K042798(SPECIAL) ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 04-NOV-04 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT INTUITIVE SURGICAL, INC. 510(k) NO: K042855(SPECIAL) ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100 950 KIFER RD. SE DECISION MADE: 12-NOV-04 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHE INVATEC INNOVATIVE TECHNOLOGIES 510(k) NO: K042537(TRADITIONAL) ATTN: MIKE WINEGAR PHONE NO : 763-398-7225 4600 NATHAN LANE NORTH SE DECISION MADE: 08-NOV-04 PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER INVATEC INNOVATIVE TECHNOLOGIES 510(k) NO: K042538(TRADITIONAL) ATTN: MIKE WINEGAR PHONE NO : 763-398-7225 4600 NATHAN LANE NORTH SE DECISION MADE: 08-NOV-04 PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE E IRVINE BIOMEDICAL, INC. 510(k) NO: K042775(SPECIAL) ATTN: BONNIE BISHOP PHONE NO : 949-851-3053 2375 MORSE AVE. SE DECISION MADE: 04-NOV-04 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TETRIC EVOCERAM IVOCLAR VIVADENT, INC. 510(k) NO: K042819(TRADITIONAL) ATTN: DONNA HARTNETT PHONE NO : 716-691-2260 175 PINEVIEW DR. SE DECISION MADE: 09-NOV-04 AMHERST, NY 14228 510(k) STATEMENT DEVICE: FRC POSTEC PLUS IVOCLAR VIVADENT, INC. 510(k) NO: K042848(TRADITIONAL) ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 22-NOV-04 AMHERST, NY 14228 510(k) STATEMENT DEVICE: K.E.P. CONNECTOR AND CLIP K.E.P., LLC 510(k) NO: K042900(TRADITIONAL) ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 05-NOV-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KASIOS TCP KASIOS BIOMATERIALS 510(k) NO: K042340(TRADITIONAL) ATTN: LAETITA BERNARD PHONE NO : 909-699-6262 45900 PARSIPPANY COURT SE DECISION MADE: 24-NOV-04 TEMECULA, CA 92592 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RONDOFLEX PLUS 360 KAVO AMERICA CORPORATION 510(k) NO: K042872(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 23-NOV-04 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENDALL CO2NFIRM NOW CO2 DETECTOR KENDALL 510(k) NO: K042572(TRADITIONAL) ATTN: BRIDGET GARDNER PHONE NO : 508-261-8532 15 HAMPSHIRE ST. SE DECISION MADE: 05-NOV-04 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEMETRON IDS CURING LIGHT KERR CORP. 510(k) NO: K042888(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 10-NOV-04 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRY LASER IMAGER, MODEL DRYPRO MODEL 793 KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K042133(TRADITIONAL) ATTN: SHINICHI YAMANAKA PHONE NO : 815 963 70190 PROGRESS SECTION SE DECISION MADE: 24-NOV-04 319 AKENO, OBATA-CHO 510(k) SUMMARY AVAILABLE FROM FDA WATARAI-GUN; MIE-KEN, JAPAN 519-05 DEVICE: CLEARFIL TRI-S BOND KURARAY MEDICAL INC. 510(k) NO: K042913(TRADITIONAL) ATTN: SATOSHI YAMAGUCHI PHONE NO : 212-986-2230 101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 26-NOV-04 NEW YORK, NY 10022 510(k) STATEMENT DEVICE: LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES ( LAGLOVE (M) SDN. BHD. 510(k) NO: K042618(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 873 35411 LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 26-NOV-04 OFF BATU 13, JALAN CHERAS 510(k) STATEMENT KAJANG, SELANGOR, DARUL EHSAN, MALAYSIA 43000 DEVICE: IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) LIFEPOINT,INC 510(k) NO: K041746(TRADITIONAL) ATTN: DAVID B GOLDBERG, PH.D. PHONE NO : 909-418-3048 1205 SOUTH DUPONT ST. SE DECISION MADE: 23-NOV-04 ONTARIO, CA 91761 510(k) STATEMENT DEVICE: IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) LIFEPOINT,INC 510(k) NO: K041747(TRADITIONAL) ATTN: DAVID B GOLDBERG PHONE NO : 909-418-3048 1205 SOUTH DUPONT ST. SE DECISION MADE: 24-NOV-04 ONTARIO, CA 91761 510(k) STATEMENT DEVICE: DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCH LINVATEC BIOMATERIALS, LTD. 510(k) NO: K042966(SPECIAL) ATTN: TUIJA ANNALA PHONE NO : 358 3 3165679 HERMIANKATU 6-8L SE DECISION MADE: 19-NOV-04 TAMPERE, FINLAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULIN LINVATEC CORP. 510(k) NO: K042778(SPECIAL) ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 04-NOV-04 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIV ANTAGE DH POWER INJECTION SYSTEM MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K042744(SPECIAL) ATTN: ELLIS ROGERS PHONE NO : 513-948-4041 2111 EAST GALBRAITH RD. SE DECISION MADE: 30-NOV-04 CINCINNATI, OH 45237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEELINE MOTIV, PROPOLIS, PCA MCKINLEY, INC. 510(k) NO: K042228(TRADITIONAL) ATTN: MICHELLE PRATTE PHONE NO : 303-420-9569 4080 YOUNGFIELD ST. SE DECISION MADE: 08-NOV-04 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LE MED-GENERAL TECHNOLOGIES LLC 510(k) NO: K042382(TRADITIONAL) ATTN: PAUL MCCREIGHT PHONE NO : 239-566-8865 1016 COLLIER CENTER WAY SE DECISION MADE: 30-NOV-04 SUITE 102 510(k) STATEMENT NAPLES, FL 34110 DEVICE: 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER MEDCOMP 510(k) NO: K040328(TRADITIONAL) ATTN: ROSANNA SEVERINI PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 24-NOV-04 HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICULT IVM SYSTEM MEDI-CULT A/S 510(k) NO: K041284(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 22-NOV-04 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 MEDICAL ACTION INDUSTRIES, INC. 510(k) NO: K042527(TRADITIONAL) ATTN: ROBIN BLANKENBAKER PHONE NO : 828-681-8820 25 HEYWOOD RD. SE DECISION MADE: 08-NOV-04 ARDEN, NC 28704 510(k) STATEMENT DEVICE: MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K042717(TRADITIONAL) ATTN: MARY THORSNESS PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 05-NOV-04 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (S MEDICAL DESIGNS, LLC 510(k) NO: K042359(TRADITIONAL) ATTN: PAUL JOHN AXT PHONE NO : 605-376-6008 1210 W. 18TH ST. SE DECISION MADE: 17-NOV-04 NORTH CENTER, SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA SIOUX FALLS, SD 57104 DEVICE: ATRILAZE SOFT TISSUE ABLATION SYSTEM MEDICALCV, INC. 510(k) NO: K040744(TRADITIONAL) ATTN: DENNY STEGER PHONE NO : 651-452-3000 9725 SOUTH ROBERT TRAIL SE DECISION MADE: 30-NOV-04 INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRADE PRODICT'S SOOTHING GEL PATCH MEDTRADE PRODUCTS LTD. 510(k) NO: K030901(TRADITIONAL) ATTN: JONATHAN RANFIELD PHONE NO : 44 127 0500019 ELECTRA HOUSE SE DECISION MADE: 26-NOV-04 CREWE BUSINESS PARK CREWE 510(k) STATEMENT CHESHIRE, UNITED KINGDOM CW1 6GL DEVICE: MSD SILO SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K042210(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 04-NOV-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K042790(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 04-NOV-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K042886(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 18-NOV-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTURE ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K042922(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 19-NOV-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOBRA GPS FIXATION SYSTEM MEDTRONIC VERTELINK, INC. 510(k) NO: K042859(TRADITIONAL) ATTN: ALBERT REGO PHONE NO : 949-770-8710 27001 LA PAZ, SUITE 312 SE DECISION MADE: 24-NOV-04 MISSION VIEJO, CA 92691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT MENTOR CORP. 510(k) NO: K042851(SPECIAL) ATTN: DONNA CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DRIVE SE DECISION MADE: 09-NOV-04 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADSEAL ROOT CANAL SEALER META BIOMED CO., LTD. 510(k) NO: K042769(TRADITIONAL) ATTN: JENNY SHON PHONE NO : 718-639-7460 41-19, 77TH STREET SE DECISION MADE: 24-NOV-04 ELMHURST, NY 11373 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100 MICRO-MEGA SOCIETE ANONYME 510(k) NO: K042171(TRADITIONAL) ATTN: PHILIPPE GARCIA PHONE NO : 333 815 44231 5-12 RUE DU TUNNEL SE DECISION MADE: 10-NOV-04 CEDEX BESANCON, FRANCE 25006 510(k) STATEMENT DEVICE: MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 MINRAD, INC. 510(k) NO: K041852(TRADITIONAL) ATTN: JOHN MCNEIRNEY PHONE NO : 716-855-1068 847 MAIN ST. SE DECISION MADE: 15-NOV-04 BUFFALO, NY 14203 510(k) STATEMENT DEVICE: SMOKE EVACUATION ATTACHEMENT MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K033095(TRADITIONAL) ATTN: DAVID LOU PHONE NO : 852 242 09068 5/F GOLD KING IND. BLDG. 35 SE DECISION MADE: 17-NOV-04 TAI LIN PAI ROAD 510(k) STATEMENT KWAI CHUNG N.T., HONG KONG DEVICE: MINIMESH POLYPROPYLENE MESH MPATHY MEDICAL DEVICES, LTD. 510(k) NO: K041632(TRADITIONAL) ATTN: LOUIS J MAZZARESE PHONE NO : 203-254-3565 150 ARAN HILL ROAD SE DECISION MADE: 17-NOV-04 FAIRFIELD, CT 06824-1712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLA NATIONAL DISPLAY SYSTEMS 510(k) NO: K042353(TRADITIONAL) ATTN: RON HANSEN PHONE NO : 408-776-0085 16245 VINEYARD BLVD. SE DECISION MADE: 24-NOV-04 MORGAN HILL, CA 95037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOPLANT IMPLANT SYSTEM NEOBIOTECH CO., LTD. 510(k) NO: K042339(TRADITIONAL) ATTN: DAE KYU CHANG PHONE NO : 562-404-8466 13340E FIRESTONE BLVD. STE. J SE DECISION MADE: 02-NOV-04 SANTE FE SPRINGS, CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA NEW STAR LASERS, INC. 510(k) NO: K041323(TRADITIONAL) ATTN: DONALD V JOHNSON PHONE NO : 916-677-1912 9085 FOOTHILLS BLVD. SE DECISION MADE: 17-NOV-04 ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS INTRAVENOUS TUBING SETS ("NIVTS") NEXUS MEDICAL, LLC 510(k) NO: K041861(TRADITIONAL) ATTN: AL BOEDEKER PHONE NO : 913-451-2234 11315 STRANG LINE ROAD SE DECISION MADE: 26-NOV-04 LENEXA, KS 66215 510(k) STATEMENT DEVICE: PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-105 NOBEL BIOCARE AB 510(k) NO: K043042(TRADITIONAL) ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 18-NOV-04 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 NOUVAG AG 510(k) NO: K042434(TRADITIONAL) ATTN: ERICH FORSTER PHONE NO : 41 56 2019500 REUSSWEHRSTRASSE 1 SE DECISION MADE: 03-NOV-04 GEBENSTORF, SWITZERLAND 5412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NX STAGE WATER PURIFICATION SYSTEM NX STAGE MEDICAL INC 510(k) NO: K042089(TRADITIONAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION ST. STE 501 SE DECISION MADE: 24-NOV-04 LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 OMRON HEALTHCARE, INC. 510(k) NO: K043018(SPECIAL) ATTN: LARRY LEPLEY PHONE NO : 847-247-5733 1200 LAKESIDE DRIVE SE DECISION MADE: 10-NOV-04 BANNOCKBURN, IL 60015 510(k) STATEMENT DEVICE: OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 OPTICON MEDICAL 510(k) NO: K041983(TRADITIONAL) ATTN: GLENN D BRUNNER PHONE NO : 614-336-2000 7001 POST RD., SUITE 100 SE DECISION MADE: 17-NOV-04 DUBLIN, OH 43016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE OPUS MEDICAL, INC. 510(k) NO: K042914(SPECIAL) ATTN: LAURA N KASPEROWICZ PHONE NO : 949-234-0400 27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 12-NOV-04 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUFFPATCH ORGANOGENESIS, INC. 510(k) NO: K042809(TRADITIONAL) ATTN: PATRICK R BILBO PHONE NO : 781-401-1110 150 DAN RD. SE DECISION MADE: 02-NOV-04 CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART BITEBLOC ORIDION MEDICAL 1987 LTD. 510(k) NO: K042665(TRADITIONAL) ATTN: SANDY BROWN PHONE NO : 972 258 99115 7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 23-NOV-04 HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA JERUSALEM, ISRAEL 91450 DEVICE: QUIKREAD CRP CALIBRATOR SET ORION DIAGNOSTICA OY 510(k) NO: K042625(TRADITIONAL) ATTN: ANNIKHA RANTAMA PHONE NO : 358 104 292736 KOIVU MANKKAAN TIE 6 SE DECISION MADE: 18-NOV-04 ESPOO, FINLAND 02200 510(k) STATEMENT DEVICE: VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEM ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042475(TRADITIONAL) ATTN: MARLENE HANNA PHONE NO : 585-453-3000 100 INDIGO CREEK DR. SE DECISION MADE: 10-NOV-04 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUC ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042477(TRADITIONAL) ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253 100 INDIGO CREEK DR. SE DECISION MADE: 19-NOV-04 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042520(TRADITIONAL) ATTN: CAREY A MAYO PHONE NO : 585-453-3482 100 INDIGO CREEK DR. SE DECISION MADE: 30-NOV-04 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KI ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042521(TRADITIONAL) ATTN: MARLENE A HANNA PHONE NO : 585-453-4041 100 INDIGO CREEK DR. SE DECISION MADE: 18-NOV-04 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB P ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042643(TRADITIONAL) ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253 100 INDIGO CREEK DR. SE DECISION MADE: 18-NOV-04 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAUMACAD 1.2 ORTHOCRAT, LTD. 510(k) NO: K042816(TRADITIONAL) ATTN: ADI ICKOWICZ PHONE NO : 972 392 33666 34/3 BAR KOHVA ST. SE DECISION MADE: 10-NOV-04 TEL AVIV, ISRAEL 63427 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ORTHOFIX VOLAR DISTAL RADIAL PLATE ORTHOFIX, INC. 510(k) NO: K042766(TRADITIONAL) ATTN: NICOLLE L FERRIS PHONE NO : 469-742-2578 1720 BRAY CENTRAL DR. SE DECISION MADE: 16-NOV-04 MCKINNEY, TX 75069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K041443(SPECIAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 16-NOV-04 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP PACK & PROPER CO., LTD. 510(k) NO: K042653(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58 FU-CHIUN ST. SE DECISION MADE: 26-NOV-04 HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT DEVICE: VAG O SPECULUM, MODELS VS1, VM1, VL1 PANATREX, INC. 510(k) NO: K042950(TRADITIONAL) ATTN: KEVIN KUO PHONE NO : 714-630-5582 1648 SIERRA MADRE CIR. SE DECISION MADE: 30-NOV-04 PLACENTIA, CA 92870-6626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROGEL CANALICULAR PLUG PARTNERS IN BIOMATERIALS, INC. 510(k) NO: K040912(TRADITIONAL) ATTN: JAMES CHRISTENSEN PHONE NO : 909-305-5400 466 WEST ARROW HWY., UNIT H SE DECISION MADE: 16-NOV-04 SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROVERTER URETERAL ACCESS SHEATH PERCUTANEOUS SYSTEMS, INC. 510(k) NO: K042877(TRADITIONAL) ATTN: THOMAS LAWSON PHONE NO : 650-969-8800 1300 CRITTENDEN LANE # 301 SE DECISION MADE: 16-NOV-04 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS ORTHOPAEDIC APPLICATIONS PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K042867(TRADITIONAL) ATTN: LYNN T HARMER PHONE NO : 425-478-7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 02-NOV-04 BOTHELL, WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GEMINI GXL PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K042935(TRADITIONAL) ATTN: RAE ANN FARROW PHONE NO : 440-483-2647 595 MINER RD. SE DECISION MADE: 09-NOV-04 CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLI PHILIPS MEDIZINSYSTEME BOBLINGEN G510(k) NO: K042845(SPECIAL) ATTN: EGON PFEIL PHONE NO : 497 031 4631925 HEWLETT PACKARD STR. 2 SE DECISION MADE: 12-NOV-04 BOBINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMD-2000 INTERFERENTIAL STIMULATOR PHOENIX MEDICAL DEVICES, LLC 510(k) NO: K042881(TRADITIONAL) ATTN: JIM KLETT PHONE NO : 949-515-4492 620 NEWPORT CENTER SE DECISION MADE: 18-NOV-04 SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA NEWPORT BEACH, CA 92660 THIRD PARTY REVIEW DEVICE: PLANMED SOPHIE NUANCE CLASSIC PLANMED OY 510(k) NO: K042671(TRADITIONAL) ATTN: BOB PIENKOWSKI PHONE NO : 630-894-2200 100 NORTH GRAY AVE. SUITE A SE DECISION MADE: 19-NOV-04 ROSELLE, IL 60172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOWCARE SYSTEM POINTCARE TECHNOLOGIES INC. 510(k) NO: K041882(TRADITIONAL) ATTN: CYNTHIA A SINCLAIR PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 23-NOV-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVOSORB SHEET, MODEL FS01 POLYGANICS BV 510(k) NO: K042811(TRADITIONAL) ATTN: JAN NIEUWENHUIS PHONE NO : 315 058 86588 L.J. ZIELSTRAWEG 1 SE DECISION MADE: 08-NOV-04 GRONINGEN, NETHERLANDS 9713-GX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) POSSIS MEDICAL, INC. 510(k) NO: K042874(SPECIAL) ATTN: MARK STENOIEN PHONE NO : 763-780-4555 9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 05-NOV-04 MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STATUS FIRST STREP A PRINCETON BIOMEDITECH CORP. 510(k) NO: K040708(TRADITIONAL) ATTN: JEMO KANG PHONE NO : 732-274-1000 4242 U.S. RT. 1 SE DECISION MADE: 22-NOV-04 MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WAT QINGDAO BESTEX RUBBER & PLASTIC PR510(k) NO: K042645(TRADITIONAL) ATTN: ZECHUAN SHAO PHONE NO : 408-980-1348 2576 LAFAYETTE ST. SE DECISION MADE: 26-NOV-04 SANTA CLARA, CA 95050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBROTEK FIB R2 DIAGNOSTICS, INC. 510(k) NO: K042919(TRADITIONAL) ATTN: PEGGY S CARTER PHONE NO : 574-288-4377 412 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 29-NOV-04 SOUTH BEND, IN 46601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX CANNABINOIDS ASSSAY RANDOX LABORATORIES, LTD. 510(k) NO: K041142(TRADITIONAL) ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 23-NOV-04 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX BARBITURATE ASSAY RANDOX LABORATORIES, LTD. 510(k) NO: K041143(TRADITIONAL) ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 05-NOV-04 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: RANDOX OPIATES ASSAY RANDOX LABORATORIES, LTD. 510(k) NO: K041144(TRADITIONAL) ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 03-NOV-04 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B REMEL INC 510(k) NO: K041951(TRADITIONAL) ATTN: MARY ANN SILVIUS PHONE NO : 913-895-4054 12076 SANTA FE DRIVE SE DECISION MADE: 15-NOV-04 LENEXA, KS 66215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESTITU RESONANT MEDICAL, INC. 510(k) NO: K041937(TRADITIONAL) ATTN: SEAN M CURRY PHONE NO : 858-675-8200 16787 BERNARDO CENTER DRIVE SE DECISION MADE: 16-NOV-04 SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92128 DEVICE: CAPNOSTAT 5 RESPIRONICS NOVAMETRIX, INC. 510(k) NO: K042601(SPECIAL) ATTN: KEVIN MADER PHONE NO : 203-697-6466 5 TECHNOLOGY DR. SE DECISION MADE: 19-NOV-04 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE DIAGNOSTICS ELECSYS AFP CALSET II ROCHE DIAGNOSTICS CORP. 510(k) NO: K043095(SPECIAL) ATTN: KAY A TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 23-NOV-04 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE ROCHE DIAGNOSTICS CORP. 510(k) NO: K043175(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 24-NOV-04 PO BX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: GUIDEWIRES ROCKET MEDICAL PLC 510(k) NO: K042264(TRADITIONAL) ATTN: T. CHARLTON PHONE NO : 00 44 1914194488 WEAR INDUSTRIAL ESTATE SE DECISION MADE: 24-NOV-04 WASHINGTON, TYNE & WEAR, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS ROSTAM LTD. 510(k) NO: K042773(TRADITIONAL) ATTN: ROBERT J STAAB PHONE NO : 201-327-0035 73 FRANKLIN TPK. SE DECISION MADE: 23-NOV-04 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S&C-SELF ETCH PRIMEBOND S & C POLYMER GMBH 510(k) NO: K042614(TRADITIONAL) ATTN: CHRISTIAN BOETTCHER PHONE NO : 49 412 14830 ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 22-NOV-04 ELMSHORN, GERMANY D-25335 510(k) STATEMENT DEVICE: SHUNTCHECK (PROMETHEUS 1) SAMUEL NEFF M.D. 510(k) NO: K040021(TRADITIONAL) ATTN: SAMUEL NEFF PHONE NO : 856-672-0800 17 WHITE HORSE PIKE SE DECISION MADE: 02-NOV-04 SUITE 3 510(k) STATEMENT HADDON HEIGHTS, NJ 08035-1299 DEVICE: MX MONOAXIAL PEDICLE SCREW SCIENT'X 510(k) NO: K042964(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 22-NOV-04 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URS LP DIGITAL, MILLENNIUM, RADPRO SEDECAL S.A. 510(k) NO: K042876(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 18-NOV-04 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR SEDECAL S.A. 510(k) NO: K043002(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 18-NOV-04 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) SERADYN INC. 510(k) NO: K042307(ABBREVIATED) ATTN: JACK ROGERS PHONE NO : 317-610-3823 7998 GEORGETOWN RD. SE DECISION MADE: 03-NOV-04 SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46268 DEVICE: POWDER-FREE VINYL PATIENT EXAMINTION GLOVES SHIJIAZHUANG MANFUL LIGHT INDUSTRI510(k) NO: K042119(TRADITIONAL) ATTN: CHEN YUHONG PHONE NO : 861 065 66660125 RM 707, AVIC BLDG, SE DECISION MADE: 03-NOV-04 NO 2 DONG SAN HUAN NAN ROAD 510(k) SUMMARY AVAILABLE FROM FDA CHAOYANG; BEIJING, CHINA 10002 DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG MANFUL LIGHT INDUSTRI510(k) NO: K042120(TRADITIONAL) ATTN: CHEN YUHONG PHONE NO : 861 065 66660125 RM 707, AVIC BLDG, SE DECISION MADE: 04-NOV-04 NO 2 DONG SAN HUAN NAN ROAD 510(k) SUMMARY AVAILABLE FROM FDA CHAOYANG; BEIJING, CHINA 10002 DEVICE: 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K042617(TRADITIONAL) ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769 51 VALLEY STREAM PARKWAY SE DECISION MADE: 05-NOV-04 E-50 510(k) SUMMARY AVAILABLE FROM FDA MALVERN, PA 19355 DEVICE: X-LEONARDO SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042995(SPECIAL) ATTN: ANA LADINO PHONE NO : 610-448-1785 51 VALLEY STREAM PKWY. SE DECISION MADE: 24-NOV-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K043016(TRADITIONAL) ATTN: PATRICK J LYNCH PHONE NO : 425-557-1825 22010 S.E. 51ST ST. SE DECISION MADE: 16-NOV-04 ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K042718(TRADITIONAL) ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769 51 VALLEY STREAM PARKWAY SE DECISION MADE: 12-NOV-04 E-50 510(k) SUMMARY AVAILABLE FROM FDA MALVERN, PA 19355 DEVICE: THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K043082(TRADITIONAL) ATTN: TRACY L GRAY PHONE NO : 763-588-9873 4050 OLSON MEMORIAL HWY SE DECISION MADE: 23-NOV-04 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: SDS-4I SKYLARK DEVICE & SYSTEMS CO., LTD 510(k) NO: K034005(TRADITIONAL) ATTN: GEORGE CHIANG PHONE NO : 886 335 87677 4F, 34, SEC. 3, SE DECISION MADE: 18-NOV-04 CHUNG SHAN NORTH RD. 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI, CHINA (TAIWAN) DEVICE: SMITH & NEPHEW MODULAR HIP SMITH & NEPHEW, INC. 510(k) NO: K042127(ABBREVIATED) ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5153 1450 E. BROOKS RD. SE DECISION MADE: 19-NOV-04 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIGEN HINDFOOT FUSION NAIL SMITH & NEPHEW, INC. 510(k) NO: K043052(SPECIAL) ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5153 1450 E. BROOKS RD. SE DECISION MADE: 24-NOV-04 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOU SONOTECH, INC. 510(k) NO: K042619(SPECIAL) ATTN: MARGARET J LARSON PHONE NO : 360-671-9121 774 MARINE DR. SE DECISION MADE: 05-NOV-04 BELLINGHAM, WA 98225 510(k) STATEMENT DEVICE: T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 SPECTROS CORPORATION 510(k) NO: K040684(TRADITIONAL) ATTN: DAVID A BENARON PHONE NO : 650-851-4040 4370 ALPINE ROAD SE DECISION MADE: 05-NOV-04 SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA PORTOLA VALLEY, CA 94028 DEVICE: UNI-THREAD SPINAL SYSTEM SPINEVISION, INC. 510(k) NO: K042640(TRADITIONAL) ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776 3003 SUMMIT BLVD. STE 1400 SE DECISION MADE: 23-NOV-04 ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM STANDARD IMAGING, INC. 510(k) NO: K042733(TRADITIONAL) ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025 7601 MURPHY DR. SE DECISION MADE: 15-NOV-04 MIDDLETON, WI 53562-2766 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A STELLARTECH RESEARCH CORP. 510(k) NO: K042909(SPECIAL) ATTN: JAMES R SANTOS PHONE NO : 408-331-3145 1346 BORDEAUX DR. SE DECISION MADE: 12-NOV-04 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERDIMENSION/BRONCHUS SUPERDIMENSION LTD. 510(k) NO: K042438(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 S SE DECISION MADE: 08-NOV-04 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SY SURGICAL LASER TECHNOLOGIES, INC. 510(k) NO: K042211(TRADITIONAL) ATTN: BOB ROSE PHONE NO : 760-602-3300 147 KEYSTONE DR. SE DECISION MADE: 08-NOV-04 MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICHIP TAG SURGICAL MARKER SURGICHIP, INC. 510(k) NO: K042555(TRADITIONAL) ATTN: BRUCE WAXMAN PHONE NO : 561-694-7776 4398 HICKORY DRIVE SE DECISION MADE: 09-NOV-04 PALM GARDENS, FL 33418 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM SURGRX, INC. 510(k) NO: K043008(SPECIAL) ATTN: LINDA OLESON PHONE NO : 650-739-0920 380 PORTAGE AVE. SE DECISION MADE: 17-NOV-04 PALO ALTO, CA 94306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D3 CHROMA SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K042422(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 15-NOV-04 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS DS/COMET SYNERON MEDICAL LTD. 510(k) NO: K041959(TRADITIONAL) ATTN: AMIR WALDMAN PHONE NO : 972 67 404616 POB 550 SE DECISION MADE: 08-NOV-04 YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM SYNTHES (USA) 510(k) NO: K042365(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 18-NOV-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES SYNTHES (USA) 510(k) NO: K042895(SPECIAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 16-NOV-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM SYNTHES (USA) 510(k) NO: K042986(SPECIAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 17-NOV-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SYNTHES CRANIAL PLATES SYNTHES (USA) 510(k) NO: K042987(SPECIAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 23-NOV-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR TAIWAN KING STRONG CO., LTD. 510(k) NO: K042652(TRADITIONAL) ATTN: KE-MEN JEN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-NOV-04 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT DEVICE: MININEPH HUMAN RHEUMATOID FACTOR KIT THE BINDING SITE 510(k) NO: K041891(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 05-NOV-04 2425 WEST OLYMPIC BLVD. 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: BINDING SITE IGG SUBLCASS OLYMPUS KITS THE BINDING SITE 510(k) NO: K042152(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 22-NOV-04 2425 WEST OLYMPIC BLVD. 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: HI-ART SYSTEM TOMOTHERAPY INCORPORATED 510(k) NO: K042739(SPECIAL) ATTN: KENNETH D BUROKER PHONE NO : 608-824-2811 1240 DEMING WAY SE DECISION MADE: 03-NOV-04 MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA TOPCON CORP. 510(k) NO: K041367(TRADITIONAL) ATTN: DONALD H WINFIELD PHONE NO : 201-261-9450 37 WEST CENTURY RD. SE DECISION MADE: 05-NOV-04 PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K043078(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 17-NOV-04 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K043111(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 18-NOV-04 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: TONO-PEN TONOMETER TIP COVER TRA & ACCESSORIES 510(k) NO: K033146(TRADITIONAL) ATTN: RICHARD MASTROLEO PHONE NO : 909-305-1944 449 WEST ALLEN AVE. SUITE 107 SE DECISION MADE: 23-NOV-04 SANDIMAS, CA 91773 510(k) STATEMENT DEVICE: OMNIPULSE MINI, MODEL 2120 TRIMEDYNE, INC. 510(k) NO: K043012(TRADITIONAL) ATTN: GLENN YEIK PHONE NO : 949-951-3800 15091 BAKE PKWY. SE DECISION MADE: 17-NOV-04 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTE USA LASER BIOTECH INC. 510(k) NO: K042256(TRADITIONAL) ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433 12101 CULLEN BLVD., # A SE DECISION MADE: 17-NOV-04 HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOL-TIP RF ABLATION SYSTEM VALLEYLAB 510(k) NO: K042216(TRADITIONAL) ATTN: CHARLES COPPERBERG PHONE NO : 303-530-6247 5920 LONGBOW DR. SE DECISION MADE: 12-NOV-04 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASC-ALERT VASC-ALERT, INC. 510(k) NO: K042566(TRADITIONAL) ATTN: JOHN B KENNEDY PHONE NO : 773-334-8177 1807 WEST SUNNYSIDE AVE. SE DECISION MADE: 08-NOV-04 SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60640 DEVICE: VENTURE WIRE CONTROL CATHETER, MODEL WCC VELOCIMED INC. 510(k) NO: K042910(SPECIAL) ATTN: JOHN CARLINE PHONE NO : 763-463-4742 11400 73RD AVE NORTH STE 134 SE DECISION MADE: 22-NOV-04 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO IVENT 201 - PORTABLE VENTILATOR VERSAMED MEDICAL SYSTEMS, INC. 510(k) NO: K042468(SPECIAL) ATTN: JERRY KORTEN PHONE NO : 845-770-2840 2 BLUE HILL PLAZA SE DECISION MADE: 17-NOV-04 BLDG. 2, 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA PEARL RIVER, NY 10965 DEVICE: FUTURABOND NR VOCO GMBH 510(k) NO: K042670(TRADITIONAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 01-NOV-04 BEND, OR 97702 510(k) STATEMENT DEVICE: VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM VOLCANO THERAPEUTICS, INC. 510(k) NO: K042188(TRADITIONAL) ATTN: JAMES FARNWORTH PHONE NO : 916-638-8008 2870 KILGORE RD. SE DECISION MADE: 10-NOV-04 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FL VOLCANO THERAPEUTICS, INC. 510(k) NO: K042996(SPECIAL) ATTN: LORRY HUFFMAN PHONE NO : 916-638-9404 2870 KILGORE RD. SE DECISION MADE: 24-NOV-04 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI CHEM CAL B WAKO CHEMICALS, USA, INC. 510(k) NO: K042549(TRADITIONAL) ATTN: LORI CREASY PHONE NO : 804-714-1932 1600 BELLWOOD RD. SE DECISION MADE: 08-NOV-04 RICHMOND, VA 23237 510(k) STATEMENT DEVICE: MULTI-LIPID CALIBRATOR WAKO CHEMICALS, USA, INC. 510(k) NO: K042550(TRADITIONAL) ATTN: LORI CREASY PHONE NO : 804-714-1932 1600 BELLWOOD RD. SE DECISION MADE: 08-NOV-04 RICHMOND, VA 23237 510(k) STATEMENT DEVICE: MULTI-CHEM CALIBRATOR A WAKO CHEMICALS, USA, INC. 510(k) NO: K042551(TRADITIONAL) ATTN: LORI CREASY PHONE NO : 804-714-1932 1600 BELLWOOD RD. SE DECISION MADE: 16-NOV-04 RICHMOND, VA 23237 510(k) STATEMENT DEVICE: OTOMIMIX WALTER LORENZ SURGICAL, INC. 510(k) NO: K042516(TRADITIONAL) ATTN: KIM REED PHONE NO : 904-741-9443 1520 TRADEPORT DR. SE DECISION MADE: 08-NOV-04 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM WANDONG MEDICAL 510(k) NO: K042948(TRADITIONAL) ATTN: WANG WEIMIN PHONE NO : 86 10 65477301 NO. 7 SANJIANFANG NANLI SE DECISION MADE: 03-NOV-04 CHAOYANG DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, CHINA 100024 THIRD PARTY REVIEW DEVICE: PERFECTA FEMORAL STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K031402(TRADITIONAL) ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732 5677 AIRLINE RD. SE DECISION MADE: 22-NOV-04 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE ZEST ANCHORS, INC. 510(k) NO: K042466(SPECIAL) ATTN: PAUL ZUEST PHONE NO : 760-743-7744 2061 WINERIDGE PL., SUITE 100 SE DECISION MADE: 24-NOV-04 ESCONDIDO, CA 92029 510(k) STATEMENT DEVICE: SILHOUETTE SPINAL FIXATION SYSTEM ZIMMER SPINE, INC. 510(k) NO: K042702(SPECIAL) ATTN: TIM CRABTREE PHONE NO : 952-857-5631 7375 BUSH LAKE RD. SE DECISION MADE: 23-NOV-04 MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOU ZIMMER TRABECULAR 510(k) NO: K043061(SPECIAL) ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 23-NOV-04 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING ZIMMER, INC. 510(k) NO: K042337(SPECIAL) ATTN: DALENE BINKLEY PHONE NO : 574-372-4907 P.O. BOX 708 SE DECISION MADE: 04-NOV-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES ZIMMER, INC. 510(k) NO: K042761(TRADITIONAL) ATTN: NOAH BARTSCH PHONE NO : 574-371-8552 P.O. BOX 708 SE DECISION MADE: 17-NOV-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, ZIMMER, INC. 510(k) NO: K042776(SPECIAL) ATTN: KAREN CAIN PHONE NO : 574-372-4485 P.O. BOX 708 SE DECISION MADE: 04-NOV-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 285 TOTAL WITH SUMMARIES 227 TOTAL WITH STATEMENTS 58
Updated December 6, 2004
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