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510(k)s Final Decisions Rendered for January 2002 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JAN-2002 THROUGH 31-JAN-2002 DEVICE: EVTOOL MODEL # V. 1.0 3D LINE USA, INC. 510(k) NO: K013535(TRADITIONAL) ATTN: KAREN RIGAMONTI PHONE NO : 410-580-1730 2807 OLD COURT ROAD SE DECISION MADE: 18-JAN-02 BALTIMORE, MD 21208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3DFIS, MODEL IES-FL-101 3DSHARP, INC. 510(k) NO: K013841(TRADITIONAL) ATTN: DONALD KRIEGER PHONE NO : 412-648-9211 6425 FORWARD AVE. SE DECISION MADE: 17-JAN-02 PITTSBURGH, PA 15217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHI ADVANCED CARDIOVASCULAR SYSTEMS, I510(k) NO: K012534(TRADITIONAL) ATTN: JOANNA MROZ PHONE NO : 408-845-3956 3200 LAKESIDE DRIVE SE DECISION MADE: 24-JAN-02 SANTA CLARA, CA 95052-8167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 AIRSEP CORP. 510(k) NO: K012037(TRADITIONAL) ATTN: CHARLOTTE H HAMILTON PHONE NO : 716-691-0202 290 CREEKSIDE DR. SE DECISION MADE: 17-JAN-02 BUFFALO, NY 14228-2070 510(k) STATEMENT DEVICE: SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY ALLTRACEL PHARMA LTD. 510(k) NO: K010933(ABBREVIATED) ATTN: CHARLES H KYPER PHONE NO : 919-960-0049 103 NOLEN LANE SE DECISION MADE: 08-JAN-02 CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIC-C1Q EIA AMERICAN LABORATORY PRODUCTS CO., 510(k) NO: K012576(TRADITIONAL) ATTN: RICHARD E CONLEY PHONE NO : 603-893-8914 P.O. BOX 451 SE DECISION MADE: 29-JAN-02 WINDHAM, NH 03087 510(k) STATEMENT DEVICE: APEX MEDICAL MINI TENS APEX MEDICAL CORP. 510(k) NO: K020032(SPECIAL) ATTN: ALAN CHANG PHONE NO : 886 226 954170 10TH FL., NO. 31, LANE 169, SE DECISION MADE: 31-JAN-02 KANG NING ST. 510(k) STATEMENT SHI-CHIH, TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: DILATING TIP OBTURATOR APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K012884(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949-713-8000 22872 AVENIDA EMPRESSA SE DECISION MADE: 17-JAN-02 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD ARTHROCARE CORP. 510(k) NO: K014222(SPECIAL) ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224 595 NORTH PASTORIA AVE. SE DECISION MADE: 18-JAN-02 SUNNYVALE, CA 94085-2936 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAMAX WOVEN VELOUR VASCULAR GRAFT ATRIUM MEDICAL CORP. 510(k) NO: K013577(TRADITIONAL) ATTN: JOSEPH P PAOLO PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 25-JAN-02 HUDSON, NH 03051 510(k) STATEMENT DEVICE: MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX AUGUSTINE MEDICAL, INC. 510(k) NO: K020077(SPECIAL) ATTN: SCOTT D AUGUSTINE PHONE NO : 952-947-1200 10393 WEST 70TH ST. SE DECISION MADE: 31-JAN-02 EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINGER JOINT PROSTHESIS AVANTA ORTHOPAEDICS, INC. 510(k) NO: K013629(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 858-452-8580 9369 CARROLL PARK DRIVE, STE.A SE DECISION MADE: 25-JAN-02 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIFIX SAFETY EPIDURAL NEEDLES B. BRAUN MEDICAL, INC. 510(k) NO: K013610(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 25-JAN-02 ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM BARCO NV 510(k) NO: K013922(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 28-JAN-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA 1650 CHOLINESTERASE ASSAY BAYER DIAGNOSTICS CORP. 510(k) NO: K013750(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE SE DECISION MADE: 18-JAN-02 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANAL BAYER DIAGNOSTICS CORP. 510(k) NO: K013959(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE SE DECISION MADE: 29-JAN-02 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3420 DIGIT PULSE OXIMETER, MODEL 3420 BCI, INC. 510(k) NO: K013171(TRADITIONAL) ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100 N7 W22025 JOHNSON ROAD SE DECISION MADE: 03-JAN-02 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTI BD 510(k) NO: K011967(TRADITIONAL) ATTN: GREGORY W MORGAN PHONE NO : 201-847-4344 1 BECTON DR. MC 226 SE DECISION MADE: 23-JAN-02 FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT BECKMAN COULTER, INC. 510(k) NO: K013978(TRADITIONAL) ATTN: MARY BETH TANG PHONE NO : 714-961-3777 200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 15-JAN-02 P.O. BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA BREA, CA 92822-8000 DEVICE: SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR BECKMAN COULTER, INC. 510(k) NO: K014103(TRADITIONAL) ATTN: MARY BETH TANG PHONE NO : 714-961-3777 200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 28-JAN-02 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELD BECTON DICKINSON INFUSION THERAPY 510(k) NO: K013304(TRADITIONAL) ATTN: LESLIE WOOD PHONE NO : 801-565-2504 9450 SOUTH STATE ST. SE DECISION MADE: 02-JAN-02 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 BIOCARDIA, INC. 510(k) NO: K012749(TRADITIONAL) ATTN: DANIEL C ROSENMAN PHONE NO : 650-624-0120 384 OYSTER POINT BLVD. #6 SE DECISION MADE: 24-JAN-02 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT BIOCHECK, INC. 510(k) NO: K013062(TRADITIONAL) ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646 9418 LASAINE AVE SE DECISION MADE: 08-JAN-02 NORTHRIDGE, CA 91325 510(k) STATEMENT DEVICE: COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 00080 BIOFORM, INC. 510(k) NO: K013243(TRADITIONAL) ATTN: VICTOR M BOWERS PHONE NO : 262-835-9800 4133 COURTNEY ROAD, #10 SE DECISION MADE: 09-JAN-02 FRANKSVILLE, WI 53126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO THE MAESTRO SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K020133(SPECIAL) ATTN: DONALD E DALTON PHONE NO : 205-967-7880 ONE PERIMETER PARK SOUTH SE DECISION MADE: 25-JAN-02 SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA BIRMINGHAM, AL 35243 DEVICE: WATERLASE MILLENNIUM BIOLASE TECHNOLOGY, INC. 510(k) NO: K012511(TRADITIONAL) ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200 981 CALLE AMANECER SE DECISION MADE: 18-JAN-02 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLIGHT PCD BIOLIGHT INTERNATIONAL AB 510(k) NO: K011355(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976 6740 RIVERVIEW TERRACE SE DECISION MADE: 17-JAN-02 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM BIOMEDICAL IMPLANT TECHNOLOGY, INC510(k) NO: K013383(TRADITIONAL) ATTN: RODNEY J SHAUGHNESSY PHONE NO : 514 631 2649 206 KING ST. SE DECISION MADE: 10-JAN-02 ST. CATHERINES, ONTARIO, CANADA L2510(k) STATEMENT DEVICE: 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020045(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 30-JAN-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATRIOT PROTRUSIO CAGE BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020076(SPECIAL) ATTN: TRACY J BICKEL PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 30-JAN-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE BIOMET, INC. 510(k) NO: K012551(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639 56 EAST BELL SE DECISION MADE: 30-JAN-02 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46582 DEVICE: TRIAGE TOX DRUG SCREEN, CATALOG #94000 BIOSITE DIAGNOSTICS 510(k) NO: K012745(TRADITIONAL) ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 10-JAN-02 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLE BISCO, INC. 510(k) NO: K013519(TRADITIONAL) ATTN: STEPHEN D SMITH PHONE NO : 847-534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 17-JAN-02 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K012184(TRADITIONAL) ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968 90 BROOKSDALE DR. SE DECISION MADE: 30-JAN-02 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW BLACKSTONE MEDICAL, INC. 510(k) NO: K013558(TRADITIONAL) ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968 90 BROOKSDALE DR. SE DECISION MADE: 23-JAN-02 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOEHRINGER MRI SUCTION REGULATORY BOEHRINGER LABORATORIES 510(k) NO: K013976(TRADITIONAL) ATTN: JOHN KARPOWICZ PHONE NO : 610-278-0900 500 E. WASHINGTON STREET SE DECISION MADE: 08-JAN-02 NORRISTOWN, PA 19401 510(k) STATEMENT DEVICE: 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F M BOSTON SCIENTIFIC 510(k) NO: K020028(SPECIAL) ATTN: TODD KORNMANN PHONE NO : 763-694-5857 ONE SCIMED PLACE SE DECISION MADE: 22-JAN-02 MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATRIX DETACHABLE COILS BOSTON SCIENTIFIC, TARGET 510(k) NO: K012985(TRADITIONAL) ATTN: SETH A SCHULMAN PHONE NO : 510-440-7753 47900 BAYSIDE PARKWAY SE DECISION MADE: 31-JAN-02 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER BOSTON SCIENTIFIC/MEDI-TECH 510(k) NO: K020012(SPECIAL) ATTN: JODI L GREENIZEN PHONE NO : 518-742-4338 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 29-JAN-02 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOBST READY-TO-WEAR GAUNTLET BSN-JOBST, INC. 510(k) NO: K013852(TRADITIONAL) ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178 5825 CARNEGIE BLVD. SE DECISION MADE: 28-JAN-02 CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, A C.R. BARD, INC. 510(k) NO: K013598(TRADITIONAL) ATTN: EBORAH L HERRINGTON PHONE NO : 978-323-2216 55 TECHNOLOGY DR. SE DECISION MADE: 11-JAN-02 LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD CONQUEST PTA BALLOON DILATATION CATHETER C.R. BARD, INC. 510(k) NO: K014212(SPECIAL) ATTN: CAROL VIERLING PHONE NO : 770-385-2347 13183 HARLAND DR. SE DECISION MADE: 17-JAN-02 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 CANON U.S.A., INC. 510(k) NO: K003689(TRADITIONAL) ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602 ONE CANON PLAZA SE DECISION MADE: 02-JAN-02 LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOBALCARDIO CARDIOCOMM SOLUTIONS, INC. 510(k) NO: K013354(TRADITIONAL) ATTN: ANGELA HALWAS PHONE NO : 250 744 1822 3060 CEDAR HILL ROAD SE DECISION MADE: 31-JAN-02 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA VICTORIA, B.C., CANADA V8T 3J5 DEVICE: HUMPHREY OCT3 CARL ZEISS OPHTHALMIC SYSTEMS, INC510(k) NO: K012727(TRADITIONAL) ATTN: MELISSSA R HORNE PHONE NO : 925-557-4100 5160 HACIENDA DR. SE DECISION MADE: 31-JAN-02 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAMPOLE HS-CRP ELISA CARTER-WALLACE, INC. 510(k) NO: K011855(TRADITIONAL) ATTN: MAUREEN GARNER PHONE NO : 609-655-6345 P.O. BOX 1001 SE DECISION MADE: 08-JAN-02 HALF ACRE ROAD 510(k) SUMMARY AVAILABLE FROM FDA CRANBURY, NJ 08512 DEVICE: CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM CATHEFFECTS, LLC. 510(k) NO: K012089(TRADITIONAL) ATTN: SHAWN FOJTIK PHONE NO : 916-677-1790 1100 MELODY LANE; SUITE 108 SE DECISION MADE: 28-JAN-02 ROSEVILLE, CA 95678 510(k) STATEMENT DEVICE: VENTED VIAL ACCESS DEVICE CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K013950(TRADITIONAL) ATTN: KEITH PALUCH PHONE NO : 603-743-5988 87 VENTURE DR. SE DECISION MADE: 10-JAN-02 DOVER, NH 03820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: USA SERIES LAPAROSCOPES CIRCON ACMI 510(k) NO: K013165(TRADITIONAL) ATTN: WAYNE B STERNER PHONE NO : 805-961-3290 300 STILLWATER AVE. SE DECISION MADE: 18-JAN-02 P.O. BOX 1971 510(k) SUMMARY AVAILABLE FROM FDA STAMFORD, CT 06904-1971 DEVICE: DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 CIRCON VIDEO 510(k) NO: K011876(TRADITIONAL) ATTN: JOHN DELUCIA PHONE NO : 508-879-4835 492 OLD CONNECTICUT PATH SE DECISION MADE: 08-JAN-02 FRAMINGHAM, MA 01701-4584 510(k) STATEMENT DEVICE: COALESCENT SURGICAL U-CLIP COALESCENT SURGICAL 510(k) NO: K013664(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223 559 EAST WEDDELL DR. SE DECISION MADE: 24-JAN-02 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDENT-A100 INTRAORAL VIDEO CAMERA CONFIDENT TECHNOLOGY, INC. 510(k) NO: K013690(TRADITIONAL) ATTN: LEWIS LIN PHONE NO : 909-590-8665 13841 ROSWELL AVE. # K SE DECISION MADE: 30-JAN-02 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCENT CONFIRMA 510(k) NO: K013574(TRADITIONAL) ATTN: CHERYL SHEA PHONE NO : 425-576-3247 821 KIRKLAND AVENUE SE DECISION MADE: 15-JAN-02 KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-S CONTINUUM ELECTRO-OPTICS, INC. 510(k) NO: K014234(SPECIAL) ATTN: RONALD KOHLHARDT PHONE NO : 408-727-3240 3150 CENTRAL EXPRESSWAY SE DECISION MADE: 17-JAN-02 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMO'S COSMO TENS PF-990 MINI DIGITAL WIRELESS MASSAGE PATCH COSMO HEALTH, INC. 510(k) NO: K013507(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFLIED AVE. SE DECISION MADE: 25-JAN-02 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS CP MEDICAL 510(k) NO: K013964(SPECIAL) ATTN: MARY ANN GREENWALT PHONE NO : 503-232-1555 P.O. BOX 6724 SE DECISION MADE: 24-JAN-02 PORTLAND, OR 97208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOC BAND CRANIAL TECHNOLOGIES, INC. 510(k) NO: K014012(TRADITIONAL) ATTN: TIMOTHY R LITTLEFIELD PHONE NO : 480-505-1840 1395 WEST AUTO DR. SE DECISION MADE: 28-JAN-02 TEMPE, AZ 85284 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUI CROSSTEX INTL. 510(k) NO: K012602(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 22-JAN-02 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N LATEX LP(A) DADE BEHRING, INC. 510(k) NO: K013128(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW SITE SE DECISION MADE: 18-JAN-02 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714 DEVICE: DADE THROMBOPLASTIN C PLUS DADE BEHRING, INC. 510(k) NO: K013155(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305-480-7558 13251 NW 9TH TERRACE SE DECISION MADE: 18-JAN-02 MIAMI, FL 33182 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA S/5 WEB VIEWER DATEX-OHMEDA 510(k) NO: K013387(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 08-JAN-02 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES DATEX-OHMEDA 510(k) NO: K013389(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 10-JAN-02 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER DATEX-OHMEDA, INC. 510(k) NO: K012924(SPECIAL) ATTN: BILL EXNER PHONE NO : 608-221-1551 P.O. BOX 7550 SE DECISION MADE: 30-JAN-02 MADISON, WI 53707-7550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIBLASTER DELDENT LTD. 510(k) NO: K013969(TRADITIONAL) ATTN: ALAN EDEL PHONE NO : 723-921-1492 19 KEREN KAYEMET STREET SE DECISION MADE: 10-JAN-02 PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT DEVICE: DELSONIC 2000 DELDENT LTD. 510(k) NO: K014238(TRADITIONAL) ATTN: ALAN EDEL PHONE NO : 972 3 9049668 19 KEREN KAYEMET STREET SE DECISION MADE: 24-JAN-02 PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT DEVICE: JETSONIC 2000 DELDENT LTD. 510(k) NO: K014245(TRADITIONAL) ATTN: ALAN EDEL PHONE NO : 972 3 9049668 19 KEREN KAYEMET STREET SE DECISION MADE: 29-JAN-02 PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT DEVICE: SLEEPBITE DENTAL IMAGINEERS & ASSOCIATES 510(k) NO: K013808(TRADITIONAL) ATTN: WILLIAM A BELFER PHONE NO : 732-493-4747 804 WEST PARK AVE. SE DECISION MADE: 30-JAN-02 OCEAN, NJ 07712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TO DENTAL MANUFACTURING S.P.A 510(k) NO: K013824(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 30-JAN-02 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: COOLBLU2 DENTAL RESIN CURING DEVICE DENTAL SYSTEMS.COM, INC. 510(k) NO: K020171(SPECIAL) ATTN: SHINOBU DOI PHONE NO : 407-927-4302 1187 TADSWORTH TERRACE SE DECISION MADE: 29-JAN-02 HEATHROW, FL 32746 510(k) STATEMENT DEVICE: DEPUY FEMORAL HEADS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K011533(TRADITIONAL) ATTN: LYNNETTE WHITAKER PHONE NO : 219-371-4903 700 ORTHOPAEDIC DR. SE DECISION MADE: 28-JAN-02 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER DI-CHEM, INC. 510(k) NO: K012328(TRADITIONAL) ATTN: KEITH A BUCHHOLZ PHONE NO : 800-847-2598 12297 ENSIGN AVE. NORTH SE DECISION MADE: 18-JAN-02 CHAMPLIN, MN 55316 510(k) STATEMENT DEVICE: HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION DI-CHEM, INC. 510(k) NO: K012547(TRADITIONAL) ATTN: KEITH A BUCHHOLZ PHONE NO : 800-847-2598 12297 ENSIGN AVE. NORTH SE DECISION MADE: 18-JAN-02 CHAMPLIN, MN 55316 510(k) STATEMENT DEVICE: ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT DIABETES TECHNOLOGIES, INC. 510(k) NO: K013465(TRADITIONAL) ATTN: ARTHUR G WILLIAMS PHONE NO : 229-227-1245 216 WEST JACKSON ST. SE DECISION MADE: 22-JAN-02 THOMASVILLE, GA 31792 510(k) STATEMENT DEVICE: IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TO DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K012075(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 10-JAN-02 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MO DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K012077(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 10-JAN-02 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN DIAMEDIX CORP. 510(k) NO: K013956(TRADITIONAL) ATTN: LYNNE STIRLING PHONE NO : 305-324-2300 2140 NORTH MIAMI AVE. SE DECISION MADE: 08-JAN-02 MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE DIAMETRICS MEDICAL, INC. 510(k) NO: K013938(TRADITIONAL) ATTN: NANCY RING PHONE NO : 651-638-1250 2658 PATTON RD. SE DECISION MADE: 28-JAN-02 ROSEVILLE, MN 55113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX ADULT HOLLOWE FIBER OXYGENATOR DIDECO S.P.A. 510(k) NO: K014080(SPECIAL) ATTN: BARRY S SALL PHONE NO : 781-434-4742 195 WEST STREET SE DECISION MADE: 08-JAN-02 WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIOMED 15 DIODE LASER DIOMED, LTD. 510(k) NO: K012398(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 22-JAN-02 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGICFIL DMG USA, INC. 510(k) NO: K013571(ABBREVIATED) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 17-JAN-02 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUXATEMP/LUXATEMP SOLAR/INSTATEMP DMG USA, INC. 510(k) NO: K013674(TRADITIONAL) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 24-JAN-02 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRG QUICKMIX DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K011736(TRADITIONAL) ATTN: RICHARD DESLAURIES PHONE NO : 203-879-9422 143 WOLCOTT RD. SE DECISION MADE: 30-JAN-02 WOLCOTT, CT 06716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B DOXA CERTEX AB 510(k) NO: K011839(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5600 555 13TH STREET N.W. SE DECISION MADE: 17-JAN-02 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAMOS ANESTHETIC GAS MONITOR DRAEGER MEDICAL, INC. 510(k) NO: K012139(ABBREVIATED) ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400 3135 QUARRY RD. SE DECISION MADE: 17-JAN-02 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 DYNAMIC TECHNOLOGY CORP. 510(k) NO: K011537(TRADITIONAL) ATTN: YAW C YANG PHONE NO : 886 357 89566 SCIENCE-BASED INDUSTRIAL PARK SE DECISION MADE: 07-JAN-02 HSINCHU, CHINA (TAIWAN) R.O.C. 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EBI OMEGA 21 SYSTEM EBI, L.P. 510(k) NO: K014137(SPECIAL) ATTN: FREDERIC TESTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 16-JAN-02 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P. 510(k) NO: K014194(SPECIAL) ATTN: PATRICIA M FLOOD PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 17-JAN-02 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALINE IV FLUSH SYRINGE EMT-RX 510(k) NO: K002142(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 919-552-9689 9400 RANSDELL RD., SUITE 10 SE DECISION MADE: 28-JAN-02 RALEIGH, NC 27603 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K013442(TRADITIONAL) ATTN: JOANNA DROEGE PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 15-JAN-02 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEMENTED CALCAR HIP SYSTEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K013490(TRADITIONAL) ATTN: JOANNA DROEGE PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 17-JAN-02 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOCARE SURGICAL SYSTEM ENDOCARE, INC. 510(k) NO: K011074(TRADITIONAL) ATTN: VINCENT CUTARTELLI PHONE NO : 949-595-4770 7 STUDEBAKER SE DECISION MADE: 25-JAN-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, M ENDOTEC, INC. 510(k) NO: K012702(TRADITIONAL) ATTN: ALEX CANONACO PHONE NO : 973-762-0095 20 VALLEY STREET SE DECISION MADE: 30-JAN-02 SOUTH ORANGE, NJ 07079 510(k) STATEMENT DEVICE: FINN CHAMBER (R) EPITEST LTD. OY 510(k) NO: K013820(TRADITIONAL) ATTN: CLAWSON BOWMAN PHONE NO : 707-793-2600 1330A REDWOOD WAY SE DECISION MADE: 30-JAN-02 PETALUMA, CA 94954-1169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERICSCOPE, MODEL # PERISC1 ETHICON ENDO-SURGERY, INC. 510(k) NO: K013576(TRADITIONAL) ATTN: DOUG KENTZ PHONE NO : 513-337-8699 4545 CREEK RD. SE DECISION MADE: 25-JAN-02 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURQ/ QUALIDURA EVER-SAFETY TECHNICAL SERVICE 510(k) NO: K013116(TRADITIONAL) ATTN: DANIEL YANG PHONE NO : NO 13 ALLEY 28 LANE 108 SE DECISION MADE: 18-JAN-02 YOUNG FENG RD 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG HSIEN, TAIWAN, CHINA DEVICE: EXEL COMFORTPOINT INSULIN PEN NEEDLE EXELINT INTL. CO. 510(k) NO: K011757(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 P.O. BOX 3194 SE DECISION MADE: 23-JAN-02 CULVER CITY, CA 90231-3194 510(k) STATEMENT DEVICE: EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE EXELINT INTL. CO. 510(k) NO: K012879(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 5840 WEST CENTINELA AVE. SE DECISION MADE: 17-JAN-02 LOS ANGELES, CA 90045 510(k) STATEMENT DEVICE: SEEDNET, MODEL FP6T5, FP5T5, FP5T3 GALIL MEDICAL LTD. 510(k) NO: K011950(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEEN ST.,N.W. SE DECISION MADE: 29-JAN-02 WASHINGTON, DC 20009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRISMASATE GAMBRO RENAL PRODUCTS 510(k) NO: K013448(TRADITIONAL) ATTN: FEI LAW PHONE NO : 386-274-2811 1845 MASON AVE. SE DECISION MADE: 15-JAN-02 DAYTONA BEACH, FL 32117-5102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BICART GAMBRO RENAL PRODUCTS 510(k) NO: K013724(TRADITIONAL) ATTN: FEI LAW PHONE NO : 386-274-2811 1845 MASON AVE. SE DECISION MADE: 08-JAN-02 DAYTONA BEACH, FL 32117-5102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNA INFINITY MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS 510(k) NO: K013636(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 24-JAN-02 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ 5 GE MEDICAL SYSTEMS 510(k) NO: K014097(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. 414 SE DECISION MADE: 10-JAN-02 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) GENERAL DEVICES 510(k) NO: K013533(TRADITIONAL) ATTN: MICHAEL SMITH PHONE NO : 201-313-7075 1000 RIVER ST. SE DECISION MADE: 18-JAN-02 RIDGEFIELD, NJ 07657 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIQBOOK GENERAL ELECTRIC CO. 510(k) NO: K014206(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 16-JAN-02 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAC 5000 ECG ANALYSIS SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K014108(SPECIAL) ATTN: DAVID WAHLIG PHONE NO : 414-362-2090 8200 WEST TOWER AVE. SE DECISION MADE: 10-JAN-02 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIMSTEP PREGNANCY GERMAINE LABORATORIES, INC. 510(k) NO: K013857(TRADITIONAL) ATTN: MARTIN O'CONNOER PHONE NO : 210-692-4192 4139 GARDENDALE CENTER SE DECISION MADE: 22-JAN-02 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA SAN ANTONIO, TX 78229 DEVICE: GLOBAL HEALTHCARE VAGINAL SPECULUM GLOBAL HEALTHCARE 510(k) NO: K013835(TRADITIONAL) ATTN: ALAM AHMED PHONE NO : 770-522-7520 1144 CANTON ST., SUITE 103 SE DECISION MADE: 17-JAN-02 ROSWELL, GA 30075 510(k) STATEMENT DEVICE: WEINMANN SOMNOMASK GOTTLIEB WEINMANN 510(k) NO: K013738(TRADITIONAL) ATTN: ECKHARDT ALBERS PHONE NO : 011 494 0547020 KRONSAALSWEG 40 SE DECISION MADE: 22-JAN-02 HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES GREAT GLOVE (THAILAND) CO. LTD. 510(k) NO: K013262(TRADITIONAL) ATTN: KM LEE PHONE NO : 603 339 21992 180/3 M. 7 SRISONTHON RD. SE DECISION MADE: 22-JAN-02 T. SRISONTHON, 510(k) STATEMENT A. THALANG, PHUKET, THAILAND 83110 DEVICE: ANCURE SHEATH MODEL # 40315, 40320, 40325 GUIDANT CARDIAC AND VASCULAR SURGE510(k) NO: K003889(TRADITIONAL) ATTN: JACQUELINE J JACKSON PHONE NO : 650-470-6200 1525 O'BRIEN DR. SE DECISION MADE: 24-JAN-02 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOA GUIDANT CORP. 510(k) NO: K013833(TRADITIONAL) ATTN: JENNIFER PAE RIGGS PHONE NO : 909-914-4581 26531 YNEZ ROAD SE DECISION MADE: 16-JAN-02 TEMECULA, CA 92592-4628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP. 510(k) NO: K014007(SPECIAL) ATTN: SABA MODJARRAD PHONE NO : 408-845-1067 3200 LAKESIDE DR. SE DECISION MADE: 07-JAN-02 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTE GUIDANT CORP. 510(k) NO: K014184(SPECIAL) ATTN: SABA MODJARRAD PHONE NO : 408-845-1067 3200 LAKESIDE DR. SE DECISION MADE: 18-JAN-02 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, V GUIDANT CORP. 510(k) NO: K014250(TRADITIONAL) ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-845-1842 3200 LAKESIDE DRIVE SE DECISION MADE: 10-JAN-02 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SU GYNECARE, A DIV. OF ETHICON, INC. 510(k) NO: K013718(TRADITIONAL) ATTN: GREGORY R JONES PHONE NO : 908-218-2481 P.O. BOX 151 SE DECISION MADE: 08-JAN-02 SOMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG HOME H&C MEDICAL DEVICES SPA 510(k) NO: K012012(ABBREVIATED) ATTN: ATTILIO CASTELLI PHONE NO : 390 222 476861 VIA PISA 250 SE DECISION MADE: 17-JAN-02 SESTO SAN GIOVANNI, ITALY 20099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM HAEMONETICS CORP. 510(k) NO: K014083(SPECIAL) ATTN: JOHN SOKOLOWSKI PHONE NO : 781-356-9488 400 WOOD RD. SE DECISION MADE: 08-JAN-02 P.O. BOX 9114 510(k) SUMMARY AVAILABLE FROM FDA BRAINTREE, MA 02184 DEVICE: HL168E HEALTH & LIFE CO., LTD. 510(k) NO: K014122(SPECIAL) ATTN: SUSAN CHEN PHONE NO : 886 232 349600 6F,NO.407, CHUNG SHAN RD. SE DECISION MADE: 16-JAN-02 SEC.02, CHUNG HO CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) 235 DEVICE: BODYGEM, MODEL HB211 HEALTHETECH, INC. 510(k) NO: K010577(TRADITIONAL) ATTN: NOEL L JOHNSON PHONE NO : 408-395-8210 325 LOS GATOS-SARATOGA ROAD SE DECISION MADE: 10-JAN-02 LOS GATOS, CA 95070 510(k) STATEMENT DEVICE: ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/57 HELENA LABORATORIES 510(k) NO: K013078(TRADITIONAL) ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714 1530 LINDBERGH DR. SE DECISION MADE: 10-JAN-02 P.O. BOX 752 510(k) SUMMARY AVAILABLE FROM FDA BEAUMONT, TX 77704 DEVICE: MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEME HILL-ROM MANUFACTURING, , INC. 510(k) NO: K014094(SPECIAL) ATTN: CINDY L CROSBY PHONE NO : 919-468-2300 11000 REGENCY PKWY SE DECISION MADE: 11-JAN-02 WEST TOWER, SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA CARY, NC 27511 DEVICE: INCARE INTERMITTENT CATHETER HOLLISTER, INC. 510(k) NO: K013345(TRADITIONAL) ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849 2000 HOLLISTER DR. SE DECISION MADE: 07-JAN-02 LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETE HOLLISTER, INC. 510(k) NO: K013483(TRADITIONAL) ATTN: JOSEPH TOKARZ PHONE NO : 847-680-2849 2000 HOLLISTER DR. SE DECISION MADE: 14-JAN-02 LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 FEMORAL NAIL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K014220(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 25-JAN-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNITRAX MODULAR UNIPOLAR SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K014226(SPECIAL) ATTN: JENNIFER A DAUDELIN PHONE NO : 201-831-5379 59 ROUTE 17 SE DECISION MADE: 25-JAN-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO OPUS SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K014229(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 25-JAN-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 HUTCHINSON TECHNOLOGY, INC. 510(k) NO: K012759(TRADITIONAL) ATTN: JOSEPH ORTNER PHONE NO : 320-587-1926 40 WEST HIGHLAND PARK SE DECISION MADE: 17-JAN-02 HUTCHINSON, MN 55350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROFERA BACTERIOSTATIC WOUND DRESSING HYDROFERA, LLC. 510(k) NO: K013462(TRADITIONAL) ATTN: HEATHER H BOND PHONE NO : 860-456-0677 322 MAIN ST., SUITE 1101 SE DECISION MADE: 11-JAN-02 WILLIMANTIC, CT 06226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NLITE SYSTEM,MODEL A00-1025 ICN PHOTONICS LTD. 510(k) NO: K013461(TRADITIONAL) ATTN: MIKE KIERMAN PHONE NO : 441 554 755444 UNITS 1&2 HEOL RHOSYN, SE DECISION MADE: 17-JAN-02 DAFEN PARK 510(k) SUMMARY AVAILABLE FROM FDA LLANELLI, UNITED KINGDOM SA148QG DEVICE: NLITE SYSTEM ICN PHOTONICS LTD. 510(k) NO: K014130(SPECIAL) ATTN: IAN MORTIMER PHONE NO : 441 554 755444 UNITS 1&2 HEOL RHOSYN, SE DECISION MADE: 08-JAN-02 DAFEN PARK 510(k) STATEMENT LLANELLI, UNITED KINGDOM SA148QG DEVICE: METAVISION CLINICAL INFORMATION SYSTEM IMDSOFT, LTD. 510(k) NO: K012349(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY, SE DECISION MADE: 29-JAN-02 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ IMPLEX CORP. 510(k) NO: K010378(TRADITIONAL) ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 28-JAN-02 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTION MAX AX-4280 URINALYSIS SYSTEM INTERNATIONAL REMOTE IMAGING SYSTE510(k) NO: K013783(TRADITIONAL) ATTN: CYNTHIA J.M NOLTE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 18-JAN-02 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) S INTERPORE CROSS INTL. 510(k) NO: K014145(SPECIAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 17-JAN-02 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY INTUITIVE SURGICAL, INC. 510(k) NO: K013416(TRADITIONAL) ATTN: MICHAEL YRAMATEGUI PHONE NO : 650-237-7048 1340 WEST MIDDLEFIELD RD. SE DECISION MADE: 10-JAN-02 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K013518(TRADITIONAL) ATTN: WENDELL LEE PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 18-JAN-02 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BCC GAMMA CAMERA IS2 RESEARCH, INC. 510(k) NO: K013667(TRADITIONAL) ATTN: VICTOR WOODBURN PHONE NO : 613 228 8755 20 GURDWARA RD., BAYS 3-6 SE DECISION MADE: 28-JAN-02 NEPEAN, ONTARIO, CANADA K2E 8B3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOCHRON JR. CITRATE APTT CUVETTE ITC, INC. 510(k) NO: K014008(SPECIAL) ATTN: JOHN CLAY PHONE NO : 800-272-1252 8 OLSEN AVENUE SE DECISION MADE: 24-JAN-02 EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCITE SELF ETCH IVOCLAR VIVADENT, INC. 510(k) NO: K013584(TRADITIONAL) ATTN: DONNA M HARTNETT PHONE NO : 716-691-2260 175 PINEVIEW DR. SE DECISION MADE: 28-JAN-02 AMHERST, NY 14228 510(k) STATEMENT DEVICE: D.SIGN 53, MODEL NA1012204 IVOCLAR VIVADENT, INC. 510(k) NO: K014082(TRADITIONAL) ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 30-JAN-02 AMHERST, NY 14228 510(k) STATEMENT DEVICE: CREATINE KINASE (CK-NAC) JAS DIAGNOSTIC, INC. 510(k) NO: K013912(TRADITIONAL) ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 18-JAN-02 MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA CLEARVISION LENS IRRIGATION SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K013838(TRADITIONAL) ATTN: JAMES A LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 16-JAN-02 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAVO POLYLUX II KAVO AMERICA 510(k) NO: K013500(TRADITIONAL) ATTN: JENNIFER POTTALA PHONE NO : 800-323-8029 340 EAST MAIN ST. SE DECISION MADE: 14-JAN-02 LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTISOL LIA KMI DIAGNOSTICS, INC. 510(k) NO: K010790(TRADITIONAL) ATTN: MARK A KOWAL PHONE NO : 763-780-2955 8201 CENTRAL AVE. NE., STE. P SE DECISION MADE: 29-JAN-02 MINNEAPOLIS, MN 55432 510(k) STATEMENT DEVICE: KONICA LASER IMAGER, DRYPRO MODEL 751/752 KONICA CORP. 510(k) NO: K013052(TRADITIONAL) ATTN: SHINICHI YAMANAKA PHONE NO : 011 815 96373609 319 AKENO, OBATA-CHO SE DECISION MADE: 16-JAN-02 WATARAI-GUN 510(k) SUMMARY AVAILABLE FROM FDA MIE-KEN, JAPAN 5190501 DEVICE: CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K013303(TRADITIONAL) ATTN: TEOH CHOH SHEE PHONE NO : 605 891 5555 PT. 5054, SE DECISION MADE: 23-JAN-02 KAMUNTING INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA TAIPING, PERAK, MALAYSIA 34600 DEVICE: LIFEGUARD NASAL CPAP MASK AND ACCESSORIES LIFEGUARD MEDICAL PRODUCTS, INC. 510(k) NO: K013421(TRADITIONAL) ATTN: CRAIG JOHNSON PHONE NO : 317-837-1111 120 ELM DRIVE SE DECISION MADE: 08-JAN-02 PLAINFIELD, IN 46168 510(k) STATEMENT DEVICE: PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP LIMERICK, INC. 510(k) NO: K012275(TRADITIONAL) ATTN: PATRICIA KELLY PHONE NO : 818-566-3060 903 NORTH SAN FERNANDO BLVD. SE DECISION MADE: 07-JAN-02 SUITE 5 510(k) SUMMARY AVAILABLE FROM FDA BURBANK, CA 91504 DEVICE: MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND LOBOB LABORATORIES, INC. 510(k) NO: K014162(SPECIAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000 2000 M STREET NW # 700 SE DECISION MADE: 15-JAN-02 WASHINGTON, DC 20036-3307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMEND PERCUTANEOUS CATHETER LUMEND, INC. 510(k) NO: K011562(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223 400 CHESAPEAKE DR. SE DECISION MADE: 16-JAN-02 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PR MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K013498(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 615 62191 6TH MILES OFF JALAN MERU SE DECISION MADE: 17-JAN-02 KLANG SELANGOR, MALAYSIA 41050 510(k) STATEMENT DEVICE: POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K013554(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 615 62191 6TH MILES OFF JALAN MERU SE DECISION MADE: 17-JAN-02 KLANG SELANGOR, MALAYSIA 41050 510(k) STATEMENT DEVICE: PERCUTANEOUS INTRODUCER SET, MODEL 042294 MEDAMICUS, INC. 510(k) NO: K013120(TRADITIONAL) ATTN: DENNIS S MADISON PHONE NO : 763-559-2613 15301 HWY. 55 WEST SE DECISION MADE: 24-JAN-02 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) MEDI-GLOBE CORP. 510(k) NO: K010549(TRADITIONAL) ATTN: SCOTT KARLER PHONE NO : 480-897-2772 6202 SOUTH MAPLE AVE., SE DECISION MADE: 18-JAN-02 SUITE 131 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85283 DEVICE: PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIO MEDICAL BIO CARE SWEDEN AB 510(k) NO: K013365(TRADITIONAL) ATTN: CONNIE W HOY PHONE NO : 530-666-7616 908 STETSON STREET SE DECISION MADE: 08-JAN-02 WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR MEDICAL BIO CARE SWEDEN AB 510(k) NO: K013366(TRADITIONAL) ATTN: CONNIE W HOY PHONE NO : 530-666-7616 908 STETSON STREET SE DECISION MADE: 08-JAN-02 WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MO MEDICAL DATA ELECTRONICS, INC. 510(k) NO: K014294(SPECIAL) ATTN: GREGORY ALKIRE PHONE NO : 818-768-6411 12723 WENTWORTH ST. SE DECISION MADE: 25-JAN-02 ARLETA, CA 91331 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODYFIX MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K013391(TRADITIONAL) ATTN: CHRISTIAN MULLER PHONE NO : 490 823 296920 FEYERABENDSTRASSE 13-15 SE DECISION MADE: 11-JAN-02 SCHWABMUNCHEN, GERMANY 86830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE INTENSIVE CARE UNIT MEDICAL RESEARCH LABORATORIES, INC510(k) NO: K012766(TRADITIONAL) ATTN: JOEL ORLINSKY PHONE NO : 847-520-0300 1000 ASBURY DR. NO.17 SE DECISION MADE: 23-JAN-02 BUFFALO GROVE, IL 60089 510(k) STATEMENT DEVICE: MEDITRON II THESTERTHOSCOPE SYSTEM MEDITRON AS 510(k) NO: K013725(TRADITIONAL) ATTN: CHARLES H KYPER PHONE NO : 919-960-0049 103 NOLEN LANE SE DECISION MADE: 30-JAN-02 CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION MEDSTONE INTL., INC. 510(k) NO: K013620(TRADITIONAL) ATTN: RON BERGESON PHONE NO : 949-448-7700 100 COLUMBIA, SUITE 100 SE DECISION MADE: 22-JAN-02 ALISO VIEJO, CA 92656-4114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYS MEDTRONIC AVE, INC. 510(k) NO: K014205(SPECIAL) ATTN: KEVIN DRISCO PHONE NO : 707-541-3193 2170-A NORTHPOINT PRKWY SE DECISION MADE: 14-JAN-02 SANTA ROSA, CA 95407 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION MEDTRONIC PERCUSURGE, INC. 510(k) NO: K014223(SPECIAL) ATTN: MATT MOON PHONE NO : 408-530-2370 540 OAKMEAD PKWY SE DECISION MADE: 25-JAN-02 SUNNYVALE, CA 94085 510(k) STATEMENT DEVICE: PYRAMID ANTERIOR PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K013665(TRADITIONAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 29-JAN-02 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUTTERFLY PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K014267(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 25-JAN-02 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KNEE MODULE FOR THE STEALTHSTATION SYSTEM MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K012937(TRADITIONAL) ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200 826 COAL CREEK CIR. SE DECISION MADE: 25-JAN-02 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMULUS - DISSECTION INSTRUMENTS MEDTRONIC XOMED, INC. 510(k) NO: K014165(TRADITIONAL) ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 22-JAN-02 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SUR MEDTRONIC, INC. 510(k) NO: K013392(ABBREVIATED) ATTN: SCOTT CANDY PHONE NO : 763-391-9941 7601 NORTHLAND DRIVE SE DECISION MADE: 25-JAN-02 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREATHTEK - UBIT UBT FOR H. PYLORI MERETEK DIAGNOSTICS, INC. 510(k) NO: K014225(SPECIAL) ATTN: DENISE E SPELLMAN PHONE NO : 800-945-8252 618 GRASSMERE PARK DR., #20 SE DECISION MADE: 17-JAN-02 NASHVILLE, TN 37211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YELLOW SPECIAL METALOR TECHNOLOGIES USA 510(k) NO: K013506(TRADITIONAL) ATTN: BRUCE BARTON PHONE NO : 800-554-5504 255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 03-JAN-02 NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT DEVICE: V-GNATHOS SUPRA METALOR TECHNOLOGIES USA 510(k) NO: K013769(TRADITIONAL) ATTN: BRUCE A BARTON PHONE NO : 800-554-5504 255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 22-JAN-02 NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT DEVICE: RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM METRACOR TECHNOLOGIES, INC. 510(k) NO: K011238(TRADITIONAL) ATTN: GEORGE F MCHUGH PHONE NO : 858-793-3300 11425 SORRENTO VALLEY ROAD SE DECISION MADE: 08-JAN-02 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAORAL LENS OPTION TO SPECTROSHADE MHT OPTIC RESEARCH AG 510(k) NO: K012744(TRADITIONAL) ATTN: MARKUS ANGST PHONE NO : 011 41 18529000 MANDACHSTR. 50 SE DECISION MADE: 23-JAN-02 NIEDERHASLI, SWITZERLAND CH-8155 510(k) STATEMENT DEVICE: MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3 MICROLIFE CORP. 510(k) NO: K013485(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD. SE DECISION MADE: 17-JAN-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTAB MICROLINE, INC. 510(k) NO: K013695(TRADITIONAL) ATTN: JACQUELINE E MASSE PHONE NO : 781-239-8108 70 WALNUT STREET SE DECISION MADE: 08-JAN-02 WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: POCKETVIEW ECG SOFTWARE MICROMEDICAL INDUSTRIES, LTD. 510(k) NO: K013311(SPECIAL) ATTN: STEPHEN CRESSWELL PHONE NO : 617 557 39777 11 TECHNOLOGY DR. SE DECISION MADE: 03-JAN-02 LABRADOR, QUEENSLAND, AUSTRALIA 42510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPS320 CARDIAC STIMULATOR MICROPACE PTY. LTD. 510(k) NO: K011826(TRADITIONAL) ATTN: MICHAEL CEJNAR PHONE NO : 612 978 76166 571 CANTERBURY RD. SE DECISION MADE: 24-JAN-02 CAMPSIE, N.S.W., AUSTRALIA 2194 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR MINNESOTA MINING AND MFG. CO. 510(k) NO: K013228(TRADITIONAL) ATTN: TIERNEY NORSTED PHONE NO : 952-946-8080 5353 WAYZATA BLVD. SE DECISION MADE: 18-JAN-02 SUITE 505 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55416 DEVICE: MISONIX IRRIGATION SYSTEM MOEDL BC20P MISONIX, INC. 510(k) NO: K013417(TRADITIONAL) ATTN: ALBERT F CLANCY PHONE NO : 516-694-9555 1938 NEW HIGHWAY SE DECISION MADE: 10-JAN-02 FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 MORAX 510(k) NO: K012789(SPECIAL) ATTN: BOREK JANIK PHONE NO : 734-475-2441 13805 WATERLOO ROAD SE DECISION MADE: 17-JAN-02 CHELSEA, MI 48118 510(k) STATEMENT DEVICE: COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) MORGAN SCIENTIFIC, INC. 510(k) NO: K013752(TRADITIONAL) ATTN: PATRICK MORGAN PHONE NO : 978-521-4440 151 ESSEX ST. SE DECISION MADE: 30-JAN-02 HAVERHILL, MA 01832 510(k) STATEMENT DEVICE: PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL MRI DEVICES CORP. 510(k) NO: K013514(TRADITIONAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 02-JAN-02 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES N.S. UNI-GLOVES SDN. BHD. 510(k) NO: K013163(TRADITIONAL) ATTN: ROBERT D VANDER LEEK PHONE NO : 310-328-7981 UG HEALTHCARE (USA) INC SE DECISION MADE: 22-JAN-02 2420 CARSON ST. SUITE 125 510(k) SUMMARY AVAILABLE FROM FDA TORRANCE, CA 90501 DEVICE: WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 NELLCOR PURITAN BENNETT, INC. 510(k) NO: K014121(SPECIAL) ATTN: ANTHONY MULLIN PHONE NO : 314-654-3049 4280 HACIENDA DR. SE DECISION MADE: 11-JAN-02 PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOLEAD NEOTECH PRODUCTS, INC. 510(k) NO: K011564(TRADITIONAL) ATTN: ARNOLD M HEYMAN PHONE NO : 818-700-2600 9135-F ALABAMA AVE. SE DECISION MADE: 03-JAN-02 CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF NC-STAT NEUROMETRIX, INC. 510(k) NO: K013459(TRADITIONAL) ATTN: SHIELA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 17-JAN-02 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 NEWCARE PRODUCTS LLC. 510(k) NO: K013167(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PKWY. SE DECISION MADE: 30-JAN-02 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE ( NONIN MEDICAL, INC. 510(k) NO: K013319(TRADITIONAL) ATTN: RICHARD P BENNETT PHONE NO : 763-577-3166 2605 FERNBROOK LANE, NORTH SE DECISION MADE: 03-JAN-02 MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAT PROFILE PHOX BASIC ANALYZER NOVA BIOMEDICAL CORP. 510(k) NO: K013729(TRADITIONAL) ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800 200 PROSPECT ST. SE DECISION MADE: 15-JAN-02 WALTHAM, MA 02454-9141 510(k) STATEMENT DEVICE: NUMED MULLINS PTA CATHETER NUMED, INC. 510(k) NO: K013601(SPECIAL) ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491 2880 MAIN STREET SE DECISION MADE: 03-JAN-02 HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUMED COEFFICIENT PTV CATHETERS NUMED, INC. 510(k) NO: K014124(SPECIAL) ATTN: NICHELLE R LAFLASH PHONE NO : 315-328-4491 2880 MAIN ST. SE DECISION MADE: 16-JAN-02 HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMEN OLYMPUS OPTICAL CO., LTD. 510(k) NO: K013617(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 30-JAN-02 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM ON SITE GAS SYSTEMS, INC. 510(k) NO: K014078(TRADITIONAL) ATTN: C. BARTON GULLONG PHONE NO : 860-229-2799 100 PRODUCTION COURT SE DECISION MADE: 08-JAN-02 NEW BRITAIN, CT 06051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND OPUSDENT LTD. 510(k) NO: K014100(SPECIAL) ATTN: ARAVA HACOHEN PHONE NO : 972 977 18130 117 AHUZAH ST. SE DECISION MADE: 08-JAN-02 RA'ANANNA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUCLEOTOMY INTRADISCAL CATHETER ORATEC INTERVENTIONS, INC. 510(k) NO: K013622(TRADITIONAL) ATTN: LINDA GUTHRIE PHONE NO : 650-369-9904 3700 HAVEN CT. SE DECISION MADE: 31-JAN-02 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KPS-I, THE KIDNEY PERFUSION SOLUTION ORGAN RECOVERY SYSTEMS, INC. 510(k) NO: K013575(TRADITIONAL) ATTN: STANLEY J HARRIS PHONE NO : 843-722-6756 701 EAST BAY STREET SE DECISION MADE: 25-JAN-02 SUITE 433 510(k) SUMMARY AVAILABLE FROM FDA CHARLESTON, SC 29403 DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K013899(TRADITIONAL) ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041 100 INDIGO CREEK DR. SE DECISION MADE: 24-JAN-02 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTAEON PROBE OSTEOBIOLOGICS, INC. 510(k) NO: K013429(TRADITIONAL) ATTN: MARK Q NIEDERAUER PHONE NO : 210-690-2131 UNIVERSITY BUSINESS PARK SE DECISION MADE: 11-JAN-02 12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA SAN ANTONIO, TX 78249-3308 DEVICE: OSTEOMED BIORESORBABLE FIXATION SYSTEM OSTEOMED CORP. 510(k) NO: K012486(TRADITIONAL) ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401 3750 REALTY RD. SE DECISION MADE: 16-JAN-02 ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS PADPRO LLC. 510(k) NO: K014209(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O.BOX 7007 SE DECISION MADE: 18-JAN-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE PAIN CONCEPTS, INC. 510(k) NO: K013513(TRADITIONAL) ATTN: RUSSELL PFLUEGER PHONE NO : 949-754-3035 8001 IRVINE CENTER DRIVE SE DECISION MADE: 17-JAN-02 4TH FLOOR 510(k) STATEMENT IRVINE, CA 92618 DEVICE: MODIFICATION TO OUTBACK CATHETER PERCLOSE, INC. 510(k) NO: K014117(SPECIAL) ATTN: SEVRINA CIUCCI PHONE NO : 650-474-3164 400 SAGINAW SE DECISION MADE: 11-JAN-02 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SUPERCROSS CATHETER PERCLOSE, INC. 510(k) NO: K014118(SPECIAL) ATTN: SEVRINA CIUCCI PHONE NO : 650-474-3164 400 SAGINAW SE DECISION MADE: 11-JAN-02 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-SNARE SET PFM PRODUKTE FUR DIE MEDIZIN AG 510(k) NO: K011783(TRADITIONAL) ATTN: SALVADORE F PALOMARES PHONE NO : 949-463-6146 15 CHEROKEE STREET SE DECISION MADE: 24-JAN-02 TRABUCO CANYON, CA 92679 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, PHILIPS MEDICAL SYSTEMS 510(k) NO: K013425(TRADITIONAL) ATTN: TAMARA YOUNT PHONE NO : 206-664-5141 2401 FOURTH AVE., SUITE 500 SE DECISION MADE: 14-JAN-02 SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, PHILIPS MEDICAL SYSTEMS 510(k) NO: K014157(SPECIAL) ATTN: TAMARA YOUNT PHONE NO : 206-664-5000 2401 FOURTH AVE., SUITE 500 SE DECISION MADE: 17-JAN-02 SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 PHILIPS MEDICAL SYSTEMS 510(k) NO: K014191(TRADITIONAL) ATTN: STEVE SINGLAR PHONE NO : 978-659-2101 3000 MINUTEMAN RD. SE DECISION MADE: 07-JAN-02 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K013894(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY SE DECISION MADE: 18-JAN-02 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-3003 DEVICE: INFINION 0.6T MR IMAGING SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K013858(TRADITIONAL) ATTN: DUANE C PRASCHAN PHONE NO : 440-483-5743 595 MINER RD. SE DECISION MADE: 22-JAN-02 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V2 PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K014159(SPECIAL) ATTN: DAVE OSBORN PHONE NO : 978-659-3173 3000 MINUTEMAN RD. SE DECISION MADE: 18-JAN-02 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2376A DEVICELINK SYSTEM, MODEL M2376A PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K014181(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. MS 0491 SE DECISION MADE: 15-JAN-02 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANMED SOPHIE & PLANMED SOPHIE CLASSIC PLANMED OY 510(k) NO: K013656(TRADITIONAL) ATTN: BOB PIENKOWSKI PHONE NO : 630-953-2368 1250 GREENBRIAR, SUITE A SE DECISION MADE: 16-JAN-02 ADDISON, IL 60101 510(k) STATEMENT DEVICE: PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP PORGES S.A. 510(k) NO: K013174(ABBREVIATED) ATTN: BERNARD ISMAEL PHONE NO : 335 533 13131 USINE DU PONTET BP 89 SE DECISION MADE: 04-JAN-02 SARLAT, FRANCE 24203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NYCOCARD CRP CONTROL PRIMUS CORP. 510(k) NO: K014084(TRADITIONAL) ATTN: JIM NOFFSINGER PHONE NO : 816-523-7491 SE DECISION MADE: 07-JAN-02 510(k) STATEMENT DEVICE: PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY PSYCHEMEDICS CORP. 510(k) NO: K011185(TRADITIONAL) ATTN: WILLIAM R TISTLE PHONE NO : 617-868-7455 5832 UPLANDER WAY SE DECISION MADE: 24-JAN-02 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM PULSE METRIC, INC. 510(k) NO: K013478(SPECIAL) ATTN: ROBERT DUFFY PHONE NO : 858-480-1171 11777 SORRENTO VALLEY ROAD SE DECISION MADE: 10-JAN-02 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ QUANTECH LTD. 510(k) NO: K012943(TRADITIONAL) ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646 9418 LASAINE AVE SE DECISION MADE: 18-JAN-02 NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R&D RET-LINE KIT R & D SYSTEMS, INC. 510(k) NO: K013898(TRADITIONAL) ATTN: RALPH E HOGANCAMP PHONE NO : 612-379-2956 614 MCKINLEY PL., N.E. SE DECISION MADE: 22-JAN-02 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX CARBAMAZEPINE RANDOX LABORATORIES, LTD. 510(k) NO: K011648(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 441 849 422413 55 DIAMOND RD. SE DECISION MADE: 15-JAN-02 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: RANDOX VALPROIC ACID RANDOX LABORATORIES, LTD. 510(k) NO: K011649(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 441 849 422413 55 DIAMOND RD. SE DECISION MADE: 15-JAN-02 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: RANDOX THEOPHYLLINE RANDOX LABORATORIES, LTD. 510(k) NO: K011771(TRADITIONAL) ATTN: P ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 17-JAN-02 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: RANDOX DIGITOXIN RANDOX LABORATORIES, LTD. 510(k) NO: K012112(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 11-JAN-02 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: RAVEN BACTERIAL SPORE STRIPS RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K020026(SPECIAL) ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781 8607 PARK DR. SE DECISION MADE: 30-JAN-02 OMAHA, NE 68127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTMONITOR 2, MODEL 4000 RESPIRONICS GEORGIA, INC. 510(k) NO: K011597(ABBREVIATED) ATTN: BETSY CORTELLONI PHONE NO : 770-429-1212 175 CHASTAIN MEADOWS COURT SE DECISION MADE: 11-JAN-02 KENNESAW, GA 30144-3724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMSTAR AUTO CPAP SYSTEM RESPIRONICS, INC. 510(k) NO: K012554(SPECIAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE LANE SE DECISION MADE: 29-JAN-02 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHODIA BITE REGISTRATION MATERIAL RHODIA INC. 510(k) NO: K013859(TRADITIONAL) ATTN: ALAIN MORIN PHONE NO : 805-653-5638 320 W. STANLEY AVE SE DECISION MADE: 29-JAN-02 VENTURA, CA 93001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIBBOND - TRIAXIAL RIBBOND, INC. 510(k) NO: K013881(TRADITIONAL) ATTN: SHOSHANA RUDO DRIVER PHONE NO : 206-340-8870 1402 3RD AVE., SUITE 1030 SE DECISION MADE: 25-JAN-02 SEATTLE, WA 98101-2118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: WINNER ST-2 STIMULATOR RICH-MAR CORP. 510(k) NO: K013770(SPECIAL) ATTN: DAVID RICHARDS PHONE NO : 918-543-2222 15499 EAST 590TH RD. SE DECISION MADE: 18-JAN-02 P.O. BOX 879 510(k) STATEMENT INOLA, OK 74036 DEVICE: MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTI RICH-MAR CORP. 510(k) NO: K013771(SPECIAL) ATTN: DAVID RICHARDS PHONE NO : 918-543-2222 15499 EAST 590TH RD. SE DECISION MADE: 18-JAN-02 P.O. BOX 879 510(k) STATEMENT INOLA, OK 74036 DEVICE: LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K010033(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 10-JAN-02 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTECH POWERED WHEELCHAIR, C650PW ROC CHINESE-EUROPEAN INDUSTRIAL RE510(k) NO: K011846(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO.58, FU-CHIUN STREET, SE DECISION MADE: 18-JAN-02 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: ROCHE ACETAMINOPHEN ROCHE DIAGNOSTICS CORP. 510(k) NO: K013757(TRADITIONAL) ATTN: MIKE FLIS PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 08-JAN-02 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONI ROSSMAX INTERNATIONAL LTD. 510(k) NO: K013539(ABBREVIATED) ATTN: MICHAEL YEH PHONE NO : 011 886 226597888 12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 17-JAN-02 TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT DEVICE: ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD ROSSMAX INTERNATIONAL LTD. 510(k) NO: K013583(ABBREVIATED) ATTN: MICHAEL YEH PHONE NO : 011 886 226597888 12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 17-JAN-02 TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT DEVICE: ANTERIOR CERVICAL PLATE SYSTEM SCIENT'X 510(k) NO: K013439(TRADITIONAL) ATTN: JOANNA DROEGE PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 14-JAN-02 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOBAR SPINAL SYSTEM SCIENT'X 510(k) NO: K013447(TRADITIONAL) ATTN: JOANNA DREOGE PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 15-JAN-02 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCI-PHARM POST SECURE SCIENTIFIC PHARMACEUTICALS, INC. 510(k) NO: K013555(TRADITIONAL) ATTN: JAN A ORLOWSKI PHONE NO : 909-595-9922 3221 PRODUCER WAY SE DECISION MADE: 23-JAN-02 POMONA, CA 91768 510(k) STATEMENT DEVICE: PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS SCOTT E ALLEN CP 510(k) NO: K012804(TRADITIONAL) ATTN: SCOTT E ALLEN PHONE NO : 801-364-3100 50 SOUTH 900 EAST #1 SE DECISION MADE: 17-JAN-02 SALT LAKE CITY, UT 84102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLA SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K014055(TRADITIONAL) ATTN: CHUN C FONG PHONE NO : 605 322 3200 LT 72706, JALAN LAHAT, KAWASAN SE DECISION MADE: 28-JAN-02 PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA LAHAT, IPOH, PERAK, MALAYSIA 31500 DEVICE: SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 SEMPERIT TECHNISCHE PRODUKTE GESEL510(k) NO: K013560(ABBREVIATED) ATTN: JAY MANSOUR PHONE NO : 678-908-8180 1308 MORNINGSTAR PARK DR SE DECISION MADE: 16-JAN-02 APHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSOR SENORX, INC. 510(k) NO: K013641(TRADITIONAL) ATTN: AMY BOUCLY PHONE NO : 949-362-4800 11 COLUMBIA, SUITE A SE DECISION MADE: 29-JAN-02 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIPORT 2000 MOBILE SERVOX MEDIZINTECHNIK GMBH 510(k) NO: K013585(TRADITIONAL) ATTN: MARTIN HERBERG PHONE NO : 022 189 9000 69 SERVATIUSSTRASSE SE DECISION MADE: 28-JAN-02 POSTAL CODE 51109 510(k) STATEMENT KOLN, GERMANY 51109 DEVICE: SHARGHP A.V. FISTULA NEEDLE SET SHARGH PHARMACEUTICAL CO., INC. 510(k) NO: K013384(TRADITIONAL) ATTN: ARMAND HAMEDANI PHONE NO : 310-649-0707 5840 WEST CENTINELA AVE. SE DECISION MADE: 07-JAN-02 BUILDING 2 510(k) STATEMENT LOS ANGELES, CA 90045 DEVICE: POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND SHEN WEI (USA), INC. 510(k) NO: K013793(TRADITIONAL) ATTN: BELLE L CHOU PHONE NO : 510-429-8692 2845 WHIPPLE RD. SE DECISION MADE: 22-JAN-02 UNION CITY, CA 94587 510(k) STATEMENT DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM SHEN WEI (USA), INC. 510(k) NO: K013794(TRADITIONAL) ATTN: BELLE L CHOU PHONE NO : 510-429-8692 2845 WHIPPLE RD. SE DECISION MADE: 22-JAN-02 UNION CITY, CA 94587 510(k) STATEMENT DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM SHEN WEI (USA), INC. 510(k) NO: K013795(TRADITIONAL) ATTN: BELLE L CHOU PHONE NO : 510-429-8692 2845 WHIPPLE RD. SE DECISION MADE: 22-JAN-02 UNION CITY, CA 94587 510(k) STATEMENT DEVICE: CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 SHIRE BIOLOGICS INC. 510(k) NO: K013523(TRADITIONAL) ATTN: ANGELA ROGERS PHONE NO : 508-351-1006 WORLDWIDE REGULATORY AFFAIRS SE DECISION MADE: 07-JAN-02 10182 TELESIS COURT 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: MINI SHOPPER SHOPRIDER INTL., INC. 510(k) NO: K013927(TRADITIONAL) ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629 P.O. BOX 187 SE DECISION MADE: 28-JAN-02 NEODESHA, KS 66757 510(k) STATEMENT DEVICE: KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E SIEMENS ELEMA AB 510(k) NO: K010923(ABBREVIATED) ATTN: DIANE WURZBURGER PHONE NO : 732-321-4765 MEDICAL SOLUTIONS SE DECISION MADE: 23-JAN-02 186 WOOD AVENUE SOUTH 510(k) SUMMARY AVAILABLE FROM FDA ISELIN, NJ 08830-2770 DEVICE: INFINITY EXPLORER SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K013515(TRADITIONAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 10-JAN-02 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS INFINITY GATEWAY SUITE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K014213(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 17-JAN-02 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SABRE COMPAC SLE LIMITED 510(k) NO: K011842(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 PO BOX 12038 SE DECISION MADE: 08-JAN-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NE SMITH & NEPHEW, INC. 510(k) NO: K013870(TRADITIONAL) ATTN: JANICE HASELTON PHONE NO : 978-749-1000 160 DASCOMB RD. SE DECISION MADE: 17-JAN-02 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH SORBA MEDICAL SYSTEMS, INC. 510(k) NO: K014299(SPECIAL) ATTN: JILL BARNEY PHONE NO : 262-827-2740 165 BISHOPS WAY, SUITE 152 SE DECISION MADE: 30-JAN-02 BROOKFIELD, WI 53005 510(k) STATEMENT DEVICE: ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM SPINAL INNOVATIONS, LLC. 510(k) NO: K013196(TRADITIONAL) ATTN: KENNETH RUSSELL PHONE NO : 901-373-8855 7850 STAGE HILLS BLVD. SE DECISION MADE: 30-JAN-02 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BARTLETT, TN 38133 DEVICE: SAFE SSN MEDICAL PRODUCTS SDN. BHD. 510(k) NO: K013773(ABBREVIATED) ATTN: ANG TECK LEONG PHONE NO : 6 03 77812829 NO. 1, JALAN 203, OFF JALAN SE DECISION MADE: 24-JAN-02 TANDANG 510(k) STATEMENT PETALING JAYA, SELANGOR, MALAYSIA 46050 DEVICE: SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) ST. JUDE MEDICAL, INC. 510(k) NO: K014037(SPECIAL) ATTN: WILLIAM MCKELVEY PHONE NO : 651-415-7029 ONE LILLEHEI PLAZA SE DECISION MADE: 04-JAN-02 ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) ST. JUDE MEDICAL, INC. 510(k) NO: K014161(SPECIAL) ATTN: WILLIAM MCKELVEY PHONE NO : 651-415-7029 ONE LILLEHEI PLAZA SE DECISION MADE: 15-JAN-02 ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO SPA INTELLIGENT STARBENE 510(k) NO: K992099(TRADITIONAL) ATTN: JUDITH NIZTZSCHMAMN PHONE NO : 543 513 4240051 DAVID LUQUE 519 SE DECISION MADE: 18-JAN-02 CORDOBA, PVCIA. CORDOBA, ARGENTINA510(k) STATEMENT DEVICE: EPOCA CODR STEM AND HEAD STELKAST CO. 510(k) NO: K014049(SPECIAL) ATTN: DONALD A STEVENS PHONE NO : 412-322-8280 800 VINIAL ST. #210 SE DECISION MADE: 09-JAN-02 PITTSBURGH, PA 15212 510(k) STATEMENT DEVICE: NOTTA AMBULATORY RECORDER STELLATE SYSTEMS 510(k) NO: K013450(ABBREVIATED) ATTN: GEORGE PAPAGIANNIS PHONE NO : 514 486 1306 345 VICTORIA AVE., SUITE 300 SE DECISION MADE: 14-JAN-02 WESTMOUNT, QUEBEC, CANADA H3Z 2N2 510(k) STATEMENT DEVICE: REPROCESSED ELECTROSURGICAL ELECTRODE STERILMED, INC. 510(k) NO: K012684(TRADITIONAL) ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870 11400 73RD AVE. NORTH SE DECISION MADE: 18-JAN-02 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLICITY STARPLUS SOFT INFUSION SET STERLING MEDIVATIONS, INC. 510(k) NO: K014061(ABBREVIATED) ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470 25285 LA LOMA DR. SE DECISION MADE: 17-JAN-02 LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLICITY EASY ACCESS INFUSION SET STERLING MEDIVATIONS, INC. 510(k) NO: K014062(ABBREVIATED) ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470 25285 LA LOMA DR. SE DECISION MADE: 17-JAN-02 LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM STRYKER LEIBINGER 510(k) NO: K013775(SPECIAL) ATTN: ROBIN L ROWE PHONE NO : 877-534-2464 4100 EAST MILHAM AVE SE DECISION MADE: 08-JAN-02 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3.75MM AND 5.0MM SPLINE TWIST IMPLANT SULZER DENTAL, INC. 510(k) NO: K013494(TRADITIONAL) ATTN: FOSTER BOOP PHONE NO : 760-929-4300 1900 ASTON AVE. SE DECISION MADE: 18-JAN-02 CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPO SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K014136(SPECIAL) ATTN: MARIA E BRITTLE PHONE NO : 651-697-9797 651 CAMPUS DR. SE DECISION MADE: 17-JAN-02 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) SUPERGRADE HEALTHCARE PRODUCTS SDN510(k) NO: K014134(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 22-JAN-02 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH AL SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K013589(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 615 72328 LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 08-JAN-02 BUKIT RAHMAN PUTRA 510(k) STATEMENT SUNGAI BULOH, SELANGOR, MALAYSIA 47000 DEVICE: SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUT SURGICAL SPECIALTIES CORP. 510(k) NO: K014021(TRADITIONAL) ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000 100 DENNIS DRIVE SE DECISION MADE: 28-JAN-02 READING, PA 19606-3776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSO SURX, INC. 510(k) NO: K011190(TRADITIONAL) ATTN: ALAN CURTIS PHONE NO : 925-417-1400 6900 KOLL CENTER PKWY., #417 SE DECISION MADE: 08-JAN-02 PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWIFT LOW PROFILE CUP (PRO CUP) SWIFT DELIVERY PRODUCTS 510(k) NO: K013460(TRADITIONAL) ATTN: RICHARD G LINDSAY PHONE NO : 405-721-8227 6824 ELK CANYON RD. SE DECISION MADE: 17-JAN-02 OKLAHOMA CITY, OK 73162 510(k) STATEMENT DEVICE: POINT 4 MODIFIED SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013510(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 18-JAN-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POINT 4 TRANSLUCENT MODIFIED SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013529(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 09-JAN-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS 2 CLEAR SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013609(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 16-JAN-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVOLUTION FORMULA 2 SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013647(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 16-JAN-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIKED WASHER SYNTHES (USA) 510(k) NO: K011583(TRADITIONAL) ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 30-JAN-02 POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: SYNTHES ANKLE ARTHRODESIS PLATE SYNTHES (USA) 510(k) NO: K013415(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 11-JAN-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PUMP TUBING TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K013578(TRADITIONAL) ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL ROAD SE DECISION MADE: 22-JAN-02 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCE TETRAD CORP. 510(k) NO: K014182(TRADITIONAL) ATTN: CHARLES F HOTTINGER PHONE NO : 408-741-1006 357 INVERNESS DR. SOUTH, SE DECISION MADE: 03-JAN-02 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA ENGLEWOOD, CO 80112 THIRD PARTY REVIEW DEVICE: THERMAGE THERMACOOL TC SYSTEM THERMAGE, INC. 510(k) NO: K013639(TRADITIONAL) ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116 4058 POINT EDEN WAY SE DECISION MADE: 29-JAN-02 HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMACOL TISSUE SCIENCE LABORATORIES, PLC 510(k) NO: K013625(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600 555 THIRTEENTH ST. N.W. SE DECISION MADE: 17-JAN-02 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-ART SYSTEM TOMO THERAPY INC 510(k) NO: K013673(TRADITIONAL) ATTN: KENNETH D BUROKER PHONE NO : 608-824-0995 2228 EVERGREEN ROAD SE DECISION MADE: 28-JAN-02 MIDDLETON, WI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPTIAM SYPHILIS-G ASSAY TRINITY BIOTECH, PLC 510(k) NO: K014233(SPECIAL) ATTN: FIONA CAMPBELL PHONE NO : 011 353 12769800 IDA BUSINESS PARK BRAY SE DECISION MADE: 24-JAN-02 CO. WICKLOW, IRELAND 510(k) STATEMENT DEVICE: ERCHONIA PL2000 TUCO INNOVATIONS, INC. 510(k) NO: K012580(TRADITIONAL) ATTN: KEVIN WALL PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 17-JAN-02 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: L-25 ABSORBABLE SURIGCAL SUTURE UNITED STATES SURGICAL, A DIVISION510(k) NO: K013671(ABBREVIATED) ATTN: ROBERT ZOTT PHONE NO : 203-845-4515 150 GLOVER AVE. SE DECISION MADE: 08-JAN-02 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTREMITY COIL USA INSTRUMENTS, INC. 510(k) NO: K013592(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 08-JAN-02 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODY ARRAY COIL USA INSTRUMENTS, INC. 510(k) NO: K013594(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 22-JAN-02 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIER III PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. 510(k) NO: K013595(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 22-JAN-02 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED INFLATION DEVICES VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012480(TRADITIONAL) ATTN: MIKE SAMMON PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 22-JAN-02 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT VASCULAR SOLUTIONS, INC. 510(k) NO: K012293(TRADITIONAL) ATTN: DEBORAH L JENSEN PHONE NO : 763-656-4349 2495 XENIUM LANE NORTH SE DECISION MADE: 18-JAN-02 MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) VASOCOR, INC. 510(k) NO: K011625(TRADITIONAL) ATTN: WALTER M ROSEBROUGH PHONE NO : 305-592-7260 499 A JESSEN LANE SE DECISION MADE: 23-JAN-02 CHARLESTON, NC 29492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOCO LITE, MODEL TD-01 VENTREX, INC. 510(k) NO: K013477(TRADITIONAL) ATTN: ROBERT GUTHRIE PHONE NO : 805-658-2984 3007 BUNSEN AVE., UNIT L & K SE DECISION MADE: 17-JAN-02 VENTURA, CA 93003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION PLUS TUNA OFFICE SYSTEM VIDAMED, INC. 510(k) NO: K014224(SPECIAL) ATTN: YI CHEN PHONE NO : 510-492-4900 46107 LANDING PKWY. SE DECISION MADE: 23-JAN-02 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM VON ZEPPELIN GMBH 510(k) NO: K013091(TRADITIONAL) ATTN: DIETER VON ZEPPELIN PHONE NO : 498 979 36880 GISTLSTRASSE 99 SE DECISION MADE: 25-JAN-02 PULLACH, GERMANY D-82049 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOXAR'S CALCIUM SCORING PRODUCT VOXAR LIMITED 510(k) NO: K020140(TRADITIONAL) ATTN: CONRAD CMIN PHONE NO : 440 131 4723792 BONNINGTON BOND, 2 ANDERSON PL SE DECISION MADE: 28-JAN-02 EDINBURGH, UNITED KINGDOM EH6 5NP 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: NUTRISAFE PUR ENTERAL FEEDING TUBE VYGON CORP. 510(k) NO: K003311(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVE. SE DECISION MADE: 11-JAN-02 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: VIABAHN ENDOPROSTHESIS W.L. GORE & ASSOCIATES,INC 510(k) NO: K013648(TRADITIONAL) ATTN: TIMOTHY J RYNN PHONE NO : 928-864-3714 3750 WEST KILTIE LN. SE DECISION MADE: 08-JAN-02 FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELF-DRILLING RADIOGRAPHIC MARKER WALTER LORENZ SURGICAL, INC. 510(k) NO: K014148(SPECIAL) ATTN: KIM REED PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 17-JAN-02 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIENER LAB. ALP 405 WIENER LABORATORIES S.A.I.C. 510(k) NO: K013983(TRADITIONAL) ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191 2944 RIOBAMBA SE DECISION MADE: 28-JAN-02 ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTE WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K020019(TRADITIONAL) ATTN: YUE W CHOW PHONE NO : 011 603 87061486 LOT 1, JALAN 3, SE DECISION MADE: 23-JAN-02 KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900 DEVICE: 84 CHANNEL EEG XLTEK 510(k) NO: K014146(SPECIAL) ATTN: SONJA MARKEZ PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 14-JAN-02 OAKVILLE, CANADA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 80 CHANNEL EEG XLTEK 510(k) NO: K014147(SPECIAL) ATTN: SONJA MARKEZ PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 14-JAN-02 OAKVILLE, CANADA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE ZIMMER, INC. 510(k) NO: K013385(TRADITIONAL) ATTN: STEPHEN MCKELVEY PHONE NO : 219-372-4944 P.O. BOX 708 SE DECISION MADE: 09-JAN-02 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 304 TOTAL WITH SUMMARIES 232 TOTAL WITH STATEMENTS 72
Updated 11/25/02
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