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Medical Devices
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March 1999 510(k) Clearances
DEVICE: BACK-ON-TRAC, MODEL 101BOT "BACK-ON-TRACK",INC. 510(k) NO: K984190(TRADITIONAL) ATTN: DAVID A SCIORTINO PHONE NO : 314-947-9086 344 CLARENDON SE DECISION MADE: 15-MAR-99 ST. CHARLES, MO 63301 510(k) STATEMENT DEVICE: AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR AARON MEDICAL INDUSTRIES 510(k) NO: K984352(TRADITIONAL) ATTN: J. ROBERT SARON PHONE NO : 727-384-2323 7100 30TH AVE. NORTH SE DECISION MADE: 04-MAR-99 ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEM U3 FOR CEFUROXIME AB BIODISK 510(k) NO: K984491(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760 DALVAGEN 10 SE DECISION MADE: 09-MAR-99 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: SYSTEM U3 FOR CEPHALOTHIN AB BIODISK 510(k) NO: K984581(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760 DALVAGEN 10 SE DECISION MADE: 09-MAR-99 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: ETEST AB BIODISK 510(k) NO: K990297(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760 DALVAGEN 10 SE DECISION MADE: 22-MAR-99 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) AB BIODISK 510(k) NO: K990685(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760 DALVAGEN 10, S-169 56 SE DECISION MADE: 26-MAR-99 SOLNA, SWEDEN 510(k) STATEMENT DEVICE: RF ABBOTT LABORATORIES, INC. 510(k) NO: K990035(TRADITIONAL) ATTN: MARK LITTLEFIELD PHONE NO : 972-518-6062 1921 HURD DR. SE DECISION MADE: 08-MAR-99 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER ABX DIAGNOSTICS, INC. 510(k) NO: K990311(TRADITIONAL) ATTN: PAT AMTOWER PHONE NO : 949-489-3913 7777 CENTER AVENUE SE DECISION MADE: 31-MAR-99 SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA HUNTINGTON BEACH, CA 92647 DEVICE: NORMED BONE TRANSPORT ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K990140(TRADITIONAL) ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100 1034 PEARL STREET SE DECISION MADE: 25-MAR-99 P.O. BOX 1710 510(k) STATEMENT BROCKTON, MA 02403 DEVICE: SILKAM NONABSORBABLE SILK SURGICAL SUTURE AESCULAP 510(k) NO: K990089(TRADITIONAL) ATTN: STEVE REITZLER PHONE NO : 619-977-1465 13221 MARICOTTE PLACE SE DECISION MADE: 15-MAR-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE AESCULAP 510(k) NO: K990090(TRADITIONAL) ATTN: STEVE REITZLER PHONE NO : 619-977-1465 13221 MARICOTTE PLACE SE DECISION MADE: 22-MAR-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIR TECHNIQUES' DENTO-VAC AIR TECHNIQUES, INC. 510(k) NO: K984584(TRADITIONAL) ATTN: JOSEPH CAREY PHONE NO : 516-433-7676 70 CANTIAGUE ROCK RD. SE DECISION MADE: 22-MAR-99 HICKSVILLE, NY 11802 510(k) STATEMENT DEVICE: INTEGRITI PATIENT MONITOR ALLIANCE INSTRUMENTS 510(k) NO: K980688(TRADITIONAL) ATTN: JIM ROOKS PHONE NO : 360-882-0202 3112 NE 112TH AVE, SUITE C SE DECISION MADE: 16-MAR-99 VANCOUVER, WA 98682 510(k) STATEMENT DEVICE: NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K990453(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 600 459 32235 LOT 2716&2720, MK 7, KAWASAN SE DECISION MADE: 09-MAR-99 PERINDUSTRIAN BUKIT PANCHOR 510(k) STATEMENT NINONG TEBAL, PULAU PINANG, MALAYSIA 14300 DEVICE: ALLISON MEDICAL INSULIN SYRINGE (AMIS) ALLISON MEDICAL, INC. 510(k) NO: K984017(TRADITIONAL) ATTN: JUSTIN FERRIN PHONE NO : 303-795-1618 4301 SOUTH FEDERAL BLVD., SE DECISION MADE: 04-MAR-99 SUITE 116 510(k) STATEMENT ENGLEWOOD, CO 80110 DEVICE: ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. 510(k) NO: K983879(TRADITIONAL) ATTN: PAUL D SMOLENSKI PHONE NO : 203-269-5088 10 FAIRFIELD BLVD. SE DECISION MADE: 22-MAR-99 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVOLASE 532 LASER SYSTEM AMERICAN LASER CORP. 510(k) NO: K990725(SPECIAL) ATTN: DANIEL HOFFER PHONE NO : 801-972-1311 1832 SOUTH 3850 WEST SE DECISION MADE: 22-MAR-99 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVOLASE 532 CUTANEOUS LASER SYSTEM AMERICAN LASER MEDICAL 510(k) NO: K990780(SPECIAL) ATTN: DANIEL HOEFER PHONE NO : 801-972-1311 1832 SOUTH 3850 WEST SE DECISION MADE: 22-MAR-99 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT ARTERIAL VASCULAR ENGINEERING, INC510(k) NO: K983927(TRADITIONAL) ATTN: DEBORAH L HERRINGTON PHONE NO : 978-667-2511 129 CONCORD RD., SE DECISION MADE: 11-MAR-99 BLDG. #1, 2 & 4 510(k) SUMMARY AVAILABLE FROM FDA BILLERICA, MA 01831 DEVICE: BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B ARTHREX, INC. 510(k) NO: K983843(TRADITIONAL) ATTN: SCOTT M DURLACHER PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 12-MAR-99 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW ATLANTIS COMPONENTS, INC. 510(k) NO: K981858(TRADITIONAL) ATTN: ANDREW ZIEGLER PHONE NO : 617-661-9799 270 THIRD STREET SE DECISION MADE: 22-MAR-99 CAMBRIDGE, MA 02142-1112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHEMO MINI SPIKE PLUS B. BRAUN OF AMERICA, INC. 510(k) NO: K983794(TRADITIONAL) ATTN: MARK S ALSBERGE PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 23-MAR-99 ALLENTOWN, PA 18103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER BAUSCH & LOMB INC. 510(k) NO: K983225(TRADITIONAL) ATTN: YVONNE E MIDDLEFELL PHONE NO : 716-338-8460 1400 N. GOODMAN STREET SE DECISION MADE: 29-MAR-99 ROCHESTER, NY 14692-0450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOMETER ELITE XL BLOOD GLUCOSE METER BAYER CORP. 510(k) NO: K984006(TRADITIONAL) ATTN: GEORGE M TANCOS PHONE NO : 219-262-6928 1884 MILES AVE. SE DECISION MADE: 18-MAR-99 ELKHART, IN 46515-2004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BCI MINI-TORR PLUS, MODEL 6004 BCI INTL., INC. 510(k) NO: K984618(TRADITIONAL) ATTN: DONALD ALEXANDER PHONE NO : 414-542-3100 N7 W22025 JOHNSON ROAD SE DECISION MADE: 25-MAR-99 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF CUTINOVA THIN DRESSING BEIERSDORF-JOBT, INC. 510(k) NO: K984593(TRADITIONAL) ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178 5825 CARNEGIE BLVD. SE DECISION MADE: 01-MAR-99 CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF CUTINOVA HYDRO DRESSING BEIERSDORF-JOBT, INC. 510(k) NO: K984595(TRADITIONAL) ATTN: ANGELO R PERIERA PHONE NO : 704-551-7178 5825 CARNEGIE BLVD. SE DECISION MADE: 01-MAR-99 CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF CUTINOVA CAVITY DRESSING BEIERSDORF-JOBT, INC. 510(k) NO: K984597(TRADITIONAL) ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178 5825 CARNEGIE BLVD. SE DECISION MADE: 01-MAR-99 CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF CUTINOVA FOAM DRESSING BEIERSDORF-JOBT, INC. 510(k) NO: K984599(TRADITIONAL) ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178 5825 CARNEGIE BLVD. SE DECISION MADE: 01-MAR-99 CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILON DUAL-DRESS BIO MED SCIENCES, INC. 510(k) NO: K990042(TRADITIONAL) ATTN: MARK E DILLON PHONE NO : 610-974-8801 101 TECHNOLOGY DR. SE DECISION MADE: 19-MAR-99 BETHLEHEM, PA 18015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX BIO-DETEK, INC. 510(k) NO: K984582(TRADITIONAL) ATTN: MICHAEL R DUPELLE PHONE NO : 800-225-1310 525 NARRAGANSETT PARK DRIVE SE DECISION MADE: 16-MAR-99 PAWTUCKET, RI 02861-4323 510(k) STATEMENT DEVICE: ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 BIO-RAD LABORATORIES, INC. 510(k) NO: K990282(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 09-MAR-99 IRVINE, CA 92618-2017 510(k) STATEMENT DEVICE: ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 BIO-RAD LABORATORIES, INC. 510(k) NO: K990317(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 18-MAR-99 IRVINE, CA 92618-2017 510(k) STATEMENT DEVICE: ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 BIO-RAD LABORATORIES, INC. 510(k) NO: K990391(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 15-MAR-99 IRVINE, CA 92618-2017 510(k) STATEMENT DEVICE: ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 BIO-RAD LABORATORIES, INC. 510(k) NO: K990393(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 22-MAR-99 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E BIO-RAD LABORATORIES, INC. 510(k) NO: K990394(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 18-MAR-99 IRVINE, CA 92618-2017 510(k) STATEMENT DEVICE: ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 BIO-RAD LABORATORIES, INC. 510(k) NO: K990424(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 31-MAR-99 IRVINE, CA 92618-2017 510(k) STATEMENT DEVICE: ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 BIO-RAD LABORATORIES, INC. 510(k) NO: K990608(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO ROAD SE DECISION MADE: 30-MAR-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC. 510(k) NO: K990436(TRADITIONAL) ATTN: DANNY HODGEMAN PHONE NO : 954-421-3166 1425 EAST NEWPORT CENTER DR. SE DECISION MADE: 31-MAR-99 DEERFIELD BEACH, FL 33442 510(k) STATEMENT DEVICE: ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM BIODYNAMIC TECHNOLOGIES, INC. 510(k) NO: K990481(TRADITIONAL) ATTN: DANNY HODGEMAN PHONE NO : 954-421-3166 1425 EAST NEWPORT CENTER DRIVE SE DECISION MADE: 17-MAR-99 DEERFIELD BEACH, FL 33442 510(k) STATEMENT DEVICE: ULTIMAX CORTICAL BONE SCREWS BIODYNAMIC TECHNOLOGIES, INC. 510(k) NO: K990513(TRADITIONAL) ATTN: DANNY HODGEMAN PHONE NO : 954-421-3166 1425 EAST NEWPORT CENTER DR. SE DECISION MADE: 17-MAR-99 DEERFIELD BEACH, FL 33442 510(k) STATEMENT DEVICE: THE BIOPLATE SHUNT CONNECTOR BIOMEDICS 510(k) NO: K984583(TRADITIONAL) ATTN: BRUCE F MACKLER PHONE NO : 536 RIMPAU BOULEVARD SE DECISION MADE: 15-MAR-99 LOS ANGELES, CA 90020 510(k) STATEMENT DEVICE: TITANIUM FEMORAL COMPONENT BIOMET, INC. 510(k) NO: K981996(TRADITIONAL) ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 10-MAR-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MAXIM REMOVABLE MOLDED POLY TIBIA BIOMET, INC. 510(k) NO: K984623(TRADITIONAL) ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 05-MAR-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: LACTOSORB BONE PIN BIOMET, INC. 510(k) NO: K990291(TRADITIONAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 23-MAR-99 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSACA SYSTEM BIOSYS AB (PUBL) 510(k) NO: K984580(TRADITIONAL) ATTN: JANE B CAMPBELL PHONE NO : 914-469-4289 485 LAROE ROAD SE DECISION MADE: 12-MAR-99 CHESTER, NY 10918 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTITAK SS BUTTONS BONUTTI RESEARCH 510(k) NO: K990156(TRADITIONAL) ATTN: PATRICK BALSMANN PHONE NO : 217-342-3412 2600 SOUTH RANEY SE DECISION MADE: 05-MAR-99 EFFINGHAM, IL 62401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLO BOSTON BIOMEDICA, INC. 510(k) NO: K980351(TRADITIONAL) ATTN: DEBRA A PETIT PHONE NO : 508-580-1900 375 WEST ST. SE DECISION MADE: 05-MAR-99 WEST BRIDGEWATER, MA 02379 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND G BOSTON MEDICAL CORP. 510(k) NO: K981947(TRADITIONAL) ATTN: TIMOTHY F HAND PHONE NO : 800-458-0304 12011 GUILFORD RD. SE DECISION MADE: 03-MAR-99 ANNAPOLIS JUNCTION, MD 20701 510(k) STATEMENT DEVICE: CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K983171(TRADITIONAL) ATTN: STEVE JWANOUSKOS PHONE NO : 408-895-3529 2710 ORCHARD PKWY. SE DECISION MADE: 11-MAR-99 SAN JOSE, CA 95113 510(k) STATEMENT DEVICE: BONE ANCHOR SYSTEM III (BAS III) BOSTON SCIENTIFIC CORP. 510(k) NO: K990295(TRADITIONAL) ATTN: LORRAINE M HANLEY PHONE NO : 508-650-8172 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 05-MAR-99 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL BRAUN AG 510(k) NO: K983295(TRADITIONAL) ATTN: FRANCES E HARRISON PHONE NO : 619-458-2277 10421 PACIFIC CENTER COURT SE DECISION MADE: 15-MAR-99 SAN DIEGO, CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASO PRESS SYSTEM BRITT CORP., INC. 510(k) NO: K974393(TRADITIONAL) ATTN: J. JAMES BRITTON PHONE NO : 732-817-1122 PO BOX 547 SE DECISION MADE: 19-MAR-99 FREEHOLD, NJ 07728 510(k) STATEMENT DEVICE: TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 BUSINESS SUPPORT INTL. 510(k) NO: K990923(SPECIAL) ATTN: DAGMAR S MAESER PHONE NO : 011 312 04289591 AMSTEL 320-I SE DECISION MADE: 31-MAR-99 AMSTERDAM, NETHERLANDS 1017-AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR C.R. BARD, INC. 510(k) NO: K990514(SPECIAL) ATTN: SANDRA PERREAND PHONE NO : 978-373-1000 25 COMPUTER DR. SE DECISION MADE: 09-MAR-99 HAVERHILL, MA 01832 510(k) STATEMENT DEVICE: CCD CAMERA, MODEL 9000 CAMTRONICS, LTD. 510(k) NO: K990066(TRADITIONAL) ATTN: ROBERT KRIEDERMANN PHONE NO : 414-367-0700 MEDICAL SYSTEMS SE DECISION MADE: 17-MAR-99 900 WALNUT RIDGE DR. 510(k) SUMMARY AVAILABLE FROM FDA HARTLAND, WI 53029 DEVICE: WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHI CARADYNE, LTD. 510(k) NO: K982283(TRADITIONAL) ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 09-MAR-99 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE AST CARESIDE, INC. 510(k) NO: K990009(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 16-MAR-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 CARESIDE, INC. 510(k) NO: K990036(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 18-MAR-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. 510(k) NO: K990691(SPECIAL) ATTN: DAVID U THOMAS PHONE NO : 805-685-3729 130 CREMONA DRIVE, SUITE B SE DECISION MADE: 23-MAR-99 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUODERM HYDROACTIVE GEL WOUND DRESSING CONVATEC, A BRISTOL-MYERS SQUIBB C510(k) NO: K990368(TRADITIONAL) ATTN: ADRIENNE MCNALLY PHONE NO : 908-904-2630 200 HEADQUARTERS PARK DR. SE DECISION MADE: 26-MAR-99 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HA ABSORBENT WOUND DRESSING CONVATEC, A DIVISION OF E.R. SQUIB510(k) NO: K984388(TRADITIONAL) ATTN: ADRIIENNE MCNALLY PHONE NO : 908-904-2630 100 HEADQUARTERS PARK DRIVE SE DECISION MADE: 03-MAR-99 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR CONWAY STUART MEDICAL, INC. 510(k) NO: K983986(TRADITIONAL) ATTN: THOMAS C WEHMAN PHONE NO : 408-733-9910 735 PALOMAR ST. SE DECISION MADE: 23-MAR-99 SUNNYVALE, CA 94086 510(k) STATEMENT DEVICE: BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SE COOK UROLOGICAL, INC. 510(k) NO: K990072(TRADITIONAL) ATTN: DEBBIE SCHMIDT PHONE NO : 812-829-4891 1100 WEST MORGAN ST. SE DECISION MADE: 25-MAR-99 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOPERSURGICAL INFRARED COAGULATOR FOR ENT COOPERSURGICAL, INC. 510(k) NO: K990855(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 30-MAR-99 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TETRAFILCON A COOPERVISION, INC. 510(k) NO: K990606(SPECIAL) ATTN: BONNIE TSYMBAL PHONE NO : 716-385-6810 711 NORTH RD. SE DECISION MADE: 15-MAR-99 SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER CORDIS CORP. 510(k) NO: K990805(SPECIAL) ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332 14201 N.W. 60TH AVE. SE DECISION MADE: 15-MAR-99 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR OCCLUSION SYSTEM CORDIS ENDOVASCULAR SYSTEMS, INC. 510(k) NO: K983483(TRADITIONAL) ATTN: MARTINE D SCHNEIDER PHONE NO : 305-512-6546 14000 N.W. 57TH CT. SE DECISION MADE: 24-MAR-99 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIFIX PEDICLE SPINAL SCREW ASSEMBLY CORIN U.S.A. 510(k) NO: K990657(SPECIAL) ATTN: CRAIG CORRANCE PHONE NO : 813-977-4469 10500 UNIVERSITY CENTER DR., SE DECISION MADE: 26-MAR-99 SUITE 190 510(k) STATEMENT TAMPA, FL 33612 DEVICE: IMMUNO-TROL CONTROL CELLS COULTER CORP. 510(k) NO: K984216(TRADITIONAL) ATTN: MARION S GAIDE PHONE NO : 305-380-2594 11800 SW 147 AVENUE SE DECISION MADE: 16-MAR-99 MIAMI, FL 33169-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONT CRANBERRY (M) SDN. BHD. 510(k) NO: K984039(TRADITIONAL) ATTN: CHONG YOON TAT PHONE NO : 605 545 1055 LOT 85, JALAN PORTLAND, SE DECISION MADE: 29-MAR-99 TASEK INDUSTRIAL ESTATE 510(k) STATEMENT IPOH PERAK, MALAYSIA 31400 DEVICE: DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 DADE BEHRING, INC. 510(k) NO: K990251(TRADITIONAL) ATTN: CATHY P CRAFT PHONE NO : 302-631-6280 BLDG. 500 MAIL BOX 514 SE DECISION MADE: 31-MAR-99 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: IGG FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K990551(TRADITIONAL) ATTN: CATHY P CRAFT PHONE NO : 302-631-6280 P.O. BOX 6101 SE DECISION MADE: 25-MAR-99 ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: IMMUNOGLOBULIN A TEST SYSTEM DADE BEHRING, INC. 510(k) NO: K990552(TRADITIONAL) ATTN: CATHY P CRAFT PHONE NO : 302-631-6280 P.O. BOX 6101 SE DECISION MADE: 25-MAR-99 ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: IGM FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K990553(TRADITIONAL) ATTN: CATHY P CRAFT PHONE NO : 302-631-6280 P.O. BOX 6101 SE DECISION MADE: 22-MAR-99 ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION SPECIAL PROTEIN CALIBRATOR DADE BEHRING, INC. 510(k) NO: K990554(TRADITIONAL) ATTN: CATHY P CRAFT PHONE NO : 302-631-6280 P.O. BOX 6101 SE DECISION MADE: 22-MAR-99 ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM DANEK MEDICAL, INC. 510(k) NO: K990603(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 10-MAR-99 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAUM NEUROCUT NEUROBIOPSYNEEDLE DAUM CORP. 510(k) NO: K990278(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 30-MAR-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE DENTSPLY MIDWEST 510(k) NO: K983105(TRADITIONAL) ATTN: ROBERT BOOTH PHONE NO : 847-640-5366 901 W. OAKTON STREET SE DECISION MADE: 08-MAR-99 DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY ACE SPIDER PLATE DEPUY ACE MEDICAL CO. 510(k) NO: K990392(TRADITIONAL) ATTN: KATHLEEN DRAGOVICH PHONE NO : 310-414-6213 2260 EAST EL SEGUNDO BLVD. SE DECISION MADE: 23-MAR-99 EL SEGUNDO, CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAF DERMAPHYLYX, INC. 510(k) NO: K990438(TRADITIONAL) ATTN: ANDREW M REED PHONE NO : 303-431-6796 12106, WEST 75TH LANE SE DECISION MADE: 25-MAR-99 ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES DEXIDE, INC. 510(k) NO: K990379(SPECIAL) ATTN: JOHN CORZINE PHONE NO : 817-589-1454 7509 FLAGSTONE DR. SE DECISION MADE: 04-MAR-99 FORT WORTH, TX 76118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 DIAG CORP. 510(k) NO: K984062(TRADITIONAL) ATTN: TODD KORNMANN PHONE NO : 612-933-4700 14901 DEVEAU PLACE SE DECISION MADE: 24-MAR-99 MINNETONKA, MN 55410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE THYROGLOBULIN MODEL LKTY DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K982466(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 213-776-0180 5700 WEST 96TH STREET SE DECISION MADE: 12-MAR-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 THYROGLOBULIN MODEL L2KTY DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K982468(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 213-776-0180 5700 WEST 96TH ST. SE DECISION MADE: 12-MAR-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K983336(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 18-MAR-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBV-VCA IGG ELISA TEST SYSTEM DIAMEDIX CORP. 510(k) NO: K981812(TRADITIONAL) ATTN: NORMAN JENKINS PHONE NO : 410-995-0450 8775 M CENTRE PARK DRIVE SE DECISION MADE: 04-MAR-99 #559 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21045 DEVICE: DIDECO D920, LILLIPUT 1 TWIN RESERVOIR DIDECO S.P.A. 510(k) NO: K984322(TRADITIONAL) ATTN: BARRY SALL PHONE NO : 781-684-9201 1601 TRAPELO ROAD SE DECISION MADE: 02-MAR-99 WALTHAM, MA 02154 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS DIGIDENT LTD. 510(k) NO: K990049(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINAME PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 12-MAR-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 DILON TECHNOLOGIES INC. 510(k) NO: K984466(TRADITIONAL) ATTN: LEE H FAIRCHILD PHONE NO : 757-269-4910 12050 JEFFERSON AVE., SE DECISION MADE: 16-MAR-99 SUITE 250 510(k) SUMMARY AVAILABLE FROM FDA NEWPORT NEWS, VA 23606 DEVICE: DRG MEDIUM SCREW SYSTEM DOLPHIN MEDICAL TECHNOLOGIES, INC.510(k) NO: K990019(TRADITIONAL) ATTN: MARK G URBANSKI PHONE NO : 941-342-0414 5959 CATTLEMEN LN. SE DECISION MADE: 15-MAR-99 SARASOTA, FL 34232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORNIER MEDILAS H/2 DORNIER SURGICAL PRODUCTS, INC. 510(k) NO: K984591(TRADITIONAL) ATTN: CAROL WERNECKE PHONE NO : 770-426-1315 1155 ROBERTS BLVD. SE DECISION MADE: 26-MAR-99 KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRAGER SOLA SERIES, MODELS 1000/700/500/300 DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K984611(ABBREVIATED) ATTN: FRANK CLANZETT PHONE NO : 53/55 MOISLINGER ALLEE SE DECISION MADE: 29-MAR-99 LUEBECK, GERMANY D-23542 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM DUTCH OPHTHALMIC USA, INC. 510(k) NO: K983797(TRADITIONAL) ATTN: MARK W FURLONG PHONE NO : 603-642-8468 ONE LITTLE RIVER RD. SE DECISION MADE: 03-MAR-99 KINGSTON, NH 03848 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGITRON ELLMAN INTL., INC. 510(k) NO: K990146(TRADITIONAL) ATTN: FRANK LIN PHONE NO : 516-569-1482 1135 RAILROAD AVE., SE DECISION MADE: 17-MAR-99 ELLMAN BLDG. 510(k) STATEMENT HEWLETT, NY 11557 DEVICE: ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS EM SCIENCE 510(k) NO: K990516(TRADITIONAL) ATTN: ANNA G BENTLEY PHONE NO : 609-423-6300 480 DEMOCRAT RD. SE DECISION MADE: 31-MAR-99 GIBBSTOWN, NJ 08027 510(k) STATEMENT DEVICE: EMOX EMOX 911 CC 510(k) NO: K984081(TRADITIONAL) ATTN: IVOR DUNCAN PHONE NO : 272 185 46006 P.O. BOX 79 SE DECISION MADE: 17-MAR-99 SOMERSET WEST, SOUTH AFRICA 7129 510(k) STATEMENT DEVICE: HINGED KNEE ENCORE ORTHOPEDICS, INC. 510(k) NO: K982160(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 17-MAR-99 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AROMAPATCH ENVIS, INC. 510(k) NO: K984345(TRADITIONAL) ATTN: STEVE WOODY PHONE NO : 828-281-2109 25 HERTIAGE DRIVE SE DECISION MADE: 19-MAR-99 ASHEVILLE, NC 28806 510(k) STATEMENT DEVICE: ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA ESTECH, INC. 510(k) NO: K990573(TRADITIONAL) ATTN: ARTHUR BERTOLERO PHONE NO : 925-648-2033 4115 BLACKHAWK PLAZA CIRCLE SE DECISION MADE: 11-MAR-99 #100 510(k) SUMMARY AVAILABLE FROM FDA DANVILLE, CA 94506 DEVICE: ULTRACISION HARMONIC SCALPEL HAND PIECE ETHICON ENDO-SURGERY, INC. 510(k) NO: K990430(SPECIAL) ATTN: RUTH ANN WOOD PHONE NO : 513-483-3486 4545 CREEK RD. SE DECISION MADE: 12-MAR-99 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXMOOR SUCTION CLEARANCE KIT EXMOOR PLASTICS LTD. 510(k) NO: K990366(TRADITIONAL) ATTN: MARGARET BLACKMORE PHONE NO : 018 232 76837 LISIEUX WAY SE DECISION MADE: 05-MAR-99 TAUNTON TA12LB, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGISCOPE OPHTHALMIC CAMERA EYE TEL IMAGING, INC. 510(k) NO: K990205(TRADITIONAL) ATTN: KEVIN T QUINN PHONE NO : 703-803-8584 15078 STILLFIELD PLACE SE DECISION MADE: 26-MAR-99 CENTREVILLE, VA 20120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING FERRIS MFG. CORP. 510(k) NO: K984539(TRADITIONAL) ATTN: THEODORE THORSEN PHONE NO : 630-887-9797 16 WEST 300 83RD ST. SE DECISION MADE: 01-MAR-99 BURR RIDGE, IL 60521 510(k) STATEMENT DEVICE: FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BAND FLEXMEDICS CORP. 510(k) NO: K990765(SPECIAL) ATTN: WILLIAM C CORRIGAN, JR. PHONE NO : 612-939-0900 12400 WHITEWATER DR., #2040 SE DECISION MADE: 15-MAR-99 MINNETONKA, MN 55343 510(k) STATEMENT DEVICE: FOREFRONT DIAGNOSTICS INSTACHECK DRUG SCREEN BENZODIAZEPINES TES FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K990099(TRADITIONAL) ATTN: PERRY G RUCKER PHONE NO : 949-595-0673 23561 RIDGE ROUTE DRIVE SE DECISION MADE: 18-MAR-99 SUITE D 510(k) STATEMENT LAGUNA HILLS, CA 92653 DEVICE: FOREFRONT DIAGNOSTICS INSTACHECK DRUG SCREEN BARBITURATES TEST FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K990107(TRADITIONAL) ATTN: PERRY G RUCKER PHONE NO : 949-595-0673 23561 RIDGE ROUTE DRIVE SE DECISION MADE: 18-MAR-99 SUITE D 510(k) STATEMENT LAGUNA HILLS, CA 92653 DEVICE: GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS GAMBRO HEALTHCARE 510(k) NO: K982414(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018 1185 OAK ST. SE DECISION MADE: 26-MAR-99 LAKEWOOD, CO 80215-4498 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXATION SYSTEM GENERAL SURGICAL INNOVATIONS 510(k) NO: K983318(TRADITIONAL) ATTN: FEROLYN T POWELL PHONE NO : 408-863-2500 10460 BUBB RD. SE DECISION MADE: 01-MAR-99 CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GTI-PF4 ELISA GENETIC TESTING INSTITUTE 510(k) NO: K983379(TRADITIONAL) ATTN: MICHAEL MOGHADDAM PHONE NO : 414-792-3900 150 NORTH PATRICK BLVD. SE DECISION MADE: 09-MAR-99 BROOKFIELD, WI 53045-5837 510(k) STATEMENT DEVICE: SAPHLIFT GENZYME SURGICAL PRODUCTS 510(k) NO: K990062(TRADITIONAL) ATTN: RUTH FORSTADT PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 30-MAR-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GILTECH PLUS CONNECTING TUBE SET GILTECH PLUS, INC. 510(k) NO: K983624(TRADITIONAL) ATTN: WILLIAM J GILIAM PHONE NO : 717-686-4184 P.O. BOX 728 SE DECISION MADE: 18-MAR-99 MILFORD, PA 18337 510(k) STATEMENT DEVICE: GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28 GUIDANT CORP. 510(k) NO: K983075(TRADITIONAL) ATTN: SANDRA SUNDELL PHONE NO : 408-235-4278 3200 LAKESIDE DR. SE DECISION MADE: 03-MAR-99 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95054-2807 DEVICE: STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 S GUIDANT CORP. 510(k) NO: K983346(TRADITIONAL) ATTN: MARGARET ANDERSON PHONE NO : 408-235-3995 3200 LAKESIDE DR. SE DECISION MADE: 23-MAR-99 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING GUIDANT CORP. 510(k) NO: K984394(TRADITIONAL) ATTN: MARGARET ANDERSON PHONE NO : 408-235-3995 3200 LAKESIDE DR. SE DECISION MADE: 08-MAR-99 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH H GUIDANT CORP. 510(k) NO: K990639(SPECIAL) ATTN: MARGARET ANDERSON PHONE NO : 408-235-4032 3200 LAKESIDE DR. SE DECISION MADE: 25-MAR-99 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95054-2807 DEVICE: VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) GYNECARE, INC. 510(k) NO: K982738(TRADITIONAL) ATTN: SUSAN M ALOYAN PHONE NO : 415-614-2500 235 CONSTITUTION DR. SE DECISION MADE: 01-MAR-99 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYNEX ELECTRODES GYNEX CORP. 510(k) NO: K982739(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 12-MAR-99 PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALADDIN II MONITORING OXYGEN/AIR MONITOR HAMILTON MEDICAL, INC. 510(k) NO: K990293(SPECIAL) ATTN: TIMOTHY Y COWART PHONE NO : 770-985-1498 3371 LENORA CHURCH RD. SE DECISION MADE: 16-MAR-99 SNELLVILLE, GA 30039 510(k) STATEMENT DEVICE: AUTOMARQER HAMILTON THORNE RESEARCH 510(k) NO: K990184(TRADITIONAL) ATTN: DIARMAID DOUGLAS-HAMILTON PHONE NO : 978-921-2050 100 CUMMINGS CENTER SE DECISION MADE: 19-MAR-99 SUITE 102-C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: BLUE POWDER-FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD 510(k) NO: K990283(TRADITIONAL) ATTN: KUAN KAM HON PHONE NO : 036 342 177 9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 09-MAR-99 KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 52100 DEVICE: HARWILL MEDICAL CERVITULA CERVICAL SPATULA HARWILL MEDICAL (PTY) LTD. 510(k) NO: K983202(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P O BOX 4341 SE DECISION MADE: 15-MAR-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: ENTERO-TEST HP, MODEL #102-01 HDC CORP. 510(k) NO: K983119(TRADITIONAL) ATTN: LEN ROSS PHONE NO : 408-954-1909 2109 O'TOOLE AVE. SE DECISION MADE: 15-MAR-99 SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 HEALTHDYNE TECHNOLOGIES, INC. 510(k) NO: K983572(TRADITIONAL) ATTN: BETSY CORTELLONI PHONE NO : 770-429-2894 1255 KENNESTONE CIRCLE SE DECISION MADE: 19-MAR-99 MARIETTA, GA 30066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECTFLOW ARTERIAL CANNULA HEARTPORT, INC. 510(k) NO: K990772(SPECIAL) ATTN: MARIANNE C DRENNAN PHONE NO : 650-482-4405 700 BAY RD. SE DECISION MADE: 23-MAR-99 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOKKI DT HILLARD WELCH 510(k) NO: K980840(TRADITIONAL) ATTN: HILLARD W WELCH PHONE NO : 508-771-6777 STUTTGART, GERMANY SE DECISION MADE: 15-MAR-99 344 ANNABELLE POINT ROAD 510(k) STATEMENT CENTERVILLE, MA 02632-2402 DEVICE: ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP HOLLISTER, INC. 510(k) NO: K990456(TRADITIONAL) ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849 2000 HOLLISTER DR. SE DECISION MADE: 25-MAR-99 LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER HOWMEDICA OSTEONICS 510(k) NO: K990152(TRADITIONAL) ATTN: KATE SUTTON PHONE NO : 201-825-4900 59 ROUTE 17 SE DECISION MADE: 15-MAR-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD HOWMEDICA OSTEONICS CORP. 510(k) NO: K990598(SPECIAL) ATTN: MARYBETH NAUGHTON PHONE NO : 201-825-4900 59 ROUTE 17 SE DECISION MADE: 15-MAR-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSIRIS HUESTIS MEDICAL 510(k) NO: K981153(TRADITIONAL) ATTN: TERRY CHWALK PHONE NO : 800-972-9222 68 BUTTONWOOD STREET SE DECISION MADE: 17-MAR-99 PO BOX 718 510(k) STATEMENT BRISTOL, RI 02807-0718 DEVICE: HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS HUTCHISON INTL., INC. 510(k) NO: K983385(TRADITIONAL) ATTN: EDUARDO MARCH PHONE NO : 301-986-4440 7475 WISCONSIN AVE., SUITE 850 SE DECISION MADE: 15-MAR-99 BETHESDA, MD 20814 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NERVE BLOCK INFUSION KIT I-FLOW CORP. 510(k) NO: K984502(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 04-MAR-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOPOGRAPHIC IMAGING MARKER I.Z.I. MEDICAL PRODUCTS CORP. 510(k) NO: K990242(TRADITIONAL) ATTN: E J SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 03-MAR-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: TOPOGRAPHIC IMAGING MARKER I.Z.I. MEDICAL PRODUCTS CORP. 510(k) NO: K990298(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 03-MAR-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: TRANSFX EXTERNAL FIXATION SYSTEM IMMEDICA, INC. 510(k) NO: K984357(TRADITIONAL) ATTN: ROY BOGERT PHONE NO : 973-635-9040 100 PASSAIC AVE. SE DECISION MADE: 04-MAR-99 CHATHAM, NJ 07928-2848 510(k) STATEMENT DEVICE: IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA IMPLEX CORP. 510(k) NO: K983835(TRADITIONAL) ATTN: ROBERT POGGIE PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 15-MAR-99 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDIGO LASEROPTIC TREATMENT SYSTEM INDIGO MEDICAL, INC. 510(k) NO: K990851(TRADITIONAL) ATTN: JACQUELYN A HUGHES PHONE NO : 513-786-7987 10123 ALLIANCE RD. SE DECISION MADE: 30-MAR-99 CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL INDUSTRIELLE ENTWICKLUNG MEDIZINTE510(k) NO: K964235(TRADITIONAL) ATTN: UWE KORTH PHONE NO : 011 492 40295000 1151 HOPE STREET SE DECISION MADE: 02-MAR-99 STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUTURELESS ANCHOR INNOVASIVE DEVICES, INC. 510(k) NO: K984490(TRADITIONAL) ATTN: KATHLEEN MORAHAN PHONE NO : 508-460-8229 734 FOREST ST. SE DECISION MADE: 01-MAR-99 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG 510(k) NO: K983742(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 RESERVOIR PLACE SE DECISION MADE: 15-MAR-99 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02451 DEVICE: HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM INTEGRA LIFESCIENCES CORP. 510(k) NO: K990086(TRADITIONAL) ATTN: JUDITH E O'GRADY PHONE NO : 609-275-0500 105 MORGAN LN. SE DECISION MADE: 31-MAR-99 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBC FLOPUMP, MODEL 6000 INTERNATIONAL BIOPHYSICS CORP. 510(k) NO: K983272(TRADITIONAL) ATTN: H. DAVID SHOCKLEY, JR PHONE NO : 512-326-3244 4020 SOUTH INDUSTRIAL DR. SE DECISION MADE: 24-MAR-99 SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78744 DEVICE: SYNERGY D2 SPINAL IMPLANTS INTERPORE CROSS INTL. 510(k) NO: K984578(TRADITIONAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 23-MAR-99 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE INTERPORE CROSS INTL. 510(k) NO: K990131(TRADITIONAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 02-MAR-99 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMA SYSTEM - OLD, BARTELS ELISA - NEW INTRACEL CORP. 510(k) NO: K990664(SPECIAL) ATTN: CECILIA MATOS-ROSA PHONE NO : 301-258-5200 1330 PICCARD DR. SE DECISION MADE: 31-MAR-99 ROCKVILLE, MD 20850-4396 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHORESOR II,MODEL PM900 IOMED, INC. 510(k) NO: K982668(TRADITIONAL) ATTN: W.TIM MILLER PHONE NO : 801-975-1191 3385 WEST 1820 SOUTH SE DECISION MADE: 02-MAR-99 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D-SIGN V (R&D PROJECT DW267#17) IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990182(TRADITIONAL) ATTN: PETER P MANCUSO PHONE NO : 800-533-6825 175 PINEVIEW DR. SE DECISION MADE: 01-MAR-99 AMHERST, NY 14228 510(k) STATEMENT DEVICE: D-SIGN VI (R&D PROJECT DW266#9) IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990235(TRADITIONAL) ATTN: PETER P MANCUSO PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 01-MAR-99 AMHERST, NY 14228 510(k) STATEMENT DEVICE: MONOPAQUE IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990315(TRADITIONAL) ATTN: PETER P MANCUSO PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 04-MAR-99 AMHERST, NY 14228 510(k) STATEMENT DEVICE: EXCITE IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990534(TRADITIONAL) ATTN: PETER P MANCUSO PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 19-MAR-99 AMHERST, NY 14228 510(k) STATEMENT DEVICE: ALLROUND-E (CODE NAME RD 1710) J.F. JELENKO & CO., INC. 510(k) NO: K984587(TRADITIONAL) ATTN: TRIDIB DASGUPTA PHONE NO : 914-273-8600 99 BUSINESS PARK DR. SE DECISION MADE: 17-MAR-99 ARMONK, NY 10504 510(k) STATEMENT DEVICE: JELDENT MULTICRYL J.F. JELENKO & CO., INC. 510(k) NO: K990056(TRADITIONAL) ATTN: RAPHAEL JUDKINS PHONE NO : 800-431-1785 99 BUSINESS PARK DR. SE DECISION MADE: 25-MAR-99 ARMONK, NY 10504 510(k) STATEMENT DEVICE: ADVANCED NIBP MODULE JOHNSON & JOHNSON MEDICAL, INC. 510(k) NO: K982641(TRADITIONAL) ATTN: DARLENE T KORAB PHONE NO : 813-887-2663 4110 GEORGE ROAD SE DECISION MADE: 29-MAR-99 TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA ENDOSCOPE HOLDER KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K990334(TRADITIONAL) ATTN: KEVIN A KENNAN PHONE NO : 310-558-1500 600 CORPORATE POINTE SE DECISION MADE: 22-MAR-99 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROGLOTTOGRAPH KAY ELEMETRICS CORP. 510(k) NO: K990240(TRADITIONAL) ATTN: WILLIAM D HARBESON PHONE NO : 973-628-6200 2 BRIDGEWATER LN. SE DECISION MADE: 11-MAR-99 LINCOLN PARK, NJ 07035-1488 510(k) STATEMENT DEVICE: HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 KAY SEE DENTAL MFG. CO. 510(k) NO: K990306(TRADITIONAL) ATTN: CLARK SMITH PHONE NO : 816-842-2817 124 EAST MISSOURI AVE. SE DECISION MADE: 03-MAR-99 KANSAS CITY, MO 64106-1294 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KEELER PULSAIR 3000 NON CONTACT TONOMETER KEELER INSTRUMENTS, INC. 510(k) NO: K990257(TRADITIONAL) ATTN: EUGENE R VAN ARSDALE PHONE NO : 800-523-5620 456 PARKWAY SE DECISION MADE: 25-MAR-99 BROOMALL, PA 19008 510(k) STATEMENT DEVICE: BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER ( KING SYSTEMS CORP. 510(k) NO: K983817(TRADITIONAL) ATTN: MICHAEL A LEAGRE PHONE NO : 317-776-6823 15011 HERRIMAN BLVD. SE DECISION MADE: 01-MAR-99 NOBLESVILLE, IN 46060 510(k) STATEMENT DEVICE: LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED) LAGLOVE (M) SDN. BHD. 510(k) NO: K990415(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 5411 LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 29-MAR-99 OFF BATU 13, JALAN CHERAS 510(k) STATEMENT KAJANG, SELANGOR, D.E., MALAYSIA 43000 DEVICE: LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) LAGLOVE (M) SDN. BHD. 510(k) NO: K990420(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 5411 LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 29-MAR-99 OFF BATU 13, JALAN CHERAS 510(k) STATEMENT KAJANG, SELANGOR, D.E., MALAYSIA 43000 DEVICE: AURA DYE LASER SYSTEM (ADLS) LASERSCOPE 510(k) NO: K984424(TRADITIONAL) ATTN: PAUL H HARDIMAN PHONE NO : 408-943-0635 3052 ORCHARD DR. SE DECISION MADE: 05-MAR-99 SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LPULSA SYL-9000 OPHTHALMIC YAG LASER LIGHT-MED (USA), INC. 510(k) NO: K990075(TRADITIONAL) ATTN: THOMAS V KEELEY PHONE NO : 949-462-9434 110P VIA ESTRADA SE DECISION MADE: 30-MAR-99 LAGUNA HILLS, CA 92653 510(k) STATEMENT DEVICE: ABLATOR ELECTRODE LINVATEC CORP. 510(k) NO: K983652(TRADITIONAL) ATTN: LAURA D SENEFF PHONE NO : 727-399-5334 11311 CONCEPT BLVD. SE DECISION MADE: 23-MAR-99 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACL/APS FACS KIT LOUISVILLE APL DIAGNOSTICS, INC. 510(k) NO: K984102(TRADITIONAL) ATTN: SILVIA S PIERANGELI PHONE NO : 770-455-7129 3988 FLOWERS RD., ST. 620 SE DECISION MADE: 18-MAR-99 DORAVILLE, GA 30360 510(k) STATEMENT DEVICE: MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS LS RUBBER SDN BHD 510(k) NO: K980964(TRADITIONAL) ATTN: MOHAMAD FIRDAOS BIN MOHAMEDPHONE NO : 670-599-3704 2443 FILLMORE STREET SE DECISION MADE: 12-MAR-99 SUITE 135 510(k) STATEMENT SAN FRANCISCO, CA 91115 DEVICE: MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS LS RUBBER SDN BHD 510(k) NO: K981955(TRADITIONAL) ATTN: MOHAMAD FIRDOAS BIN MOHAMEDPHONE NO : 607-599-3923 2443 FILLMORE STREET SE DECISION MADE: 15-MAR-99 SUITE 135 510(k) STATEMENT SAN FRANCISCO, CA 91115 DEVICE: MABIS NB-02 ULTRASONIC NEBULIZER MABIS HEALTHCARE, INC. 510(k) NO: K990506(TRADITIONAL) ATTN: STEVEN M BISULCA PHONE NO : 847-680-6811 28690 BALLARD DR. SE DECISION MADE: 11-MAR-99 LAKE FOREST, IL 60045 510(k) STATEMENT DEVICE: RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) MASTEK, INC. 510(k) NO: K983918(TRADITIONAL) ATTN: MARCOS V MASSON PHONE NO : 888-406-7447 1200 BINZ, SUITE 1200 SE DECISION MADE: 12-MAR-99 HOUSTON, TX 77004 510(k) STATEMENT DEVICE: MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM MEDI-GLOBE CORP. 510(k) NO: K990220(TRADITIONAL) ATTN: MICHELLE L FIELDS PHONE NO : 800-966-1431 6202 SOUTH MAPLE AVE., SE DECISION MADE: 31-MAR-99 SUITE 131 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85283 DEVICE: PRO2 CHECK OXYGEN INDICATOR MEDICAL TECHNOLOGY SPECIALISTS, IN510(k) NO: K983500(TRADITIONAL) ATTN: DONALD W MORROW, III PHONE NO : 804-674-0199 6290-D WARWICK RD. SE DECISION MADE: 17-MAR-99 RICHMOND, VA 23224 510(k) STATEMENT DEVICE: MEDIVISION LAPAROSCOPE MEDIVISION SCOPE SERVICE CENTER, I510(k) NO: K984434(TRADITIONAL) ATTN: WAYNE B STERNER PHONE NO : 714-563-2772 1440 S. STATE COLLEGE BLVD. SE DECISION MADE: 17-MAR-99 #1D 510(k) STATEMENT ANAHEIM, CA 92806 DEVICE: MEDLINE EXCEL WHEELCHAIRS MEDLINE 510(k) NO: K990463(TRADITIONAL) ATTN: LARA N SIMMONS PHONE NO : 847-949-2639 ONE MEDLINE PLACE SE DECISION MADE: 15-MAR-99 MUNDLELEIN, IL 60060 510(k) STATEMENT DEVICE: UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET MEDRAD, INC. 510(k) NO: K984418(TRADITIONAL) ATTN: FRANK W PELC III PHONE NO : 412-767-2400 ONE MEDRAD DRIVE SE DECISION MADE: 11-MAR-99 INIANOLA,, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTEX DERMASCAN C ULTRASONIC SYSTEM MEDSYS, INC. 510(k) NO: K983945(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SOUTH SE DECISION MADE: 17-MAR-99 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; D MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K990375(SPECIAL) ATTN: ANN-CHRISTINE JONSSON PHONE NO : 45 44 579000 TONSBAKKEN 16-18 SE DECISION MADE: 09-MAR-99 SKOVLUNDE 510(k) SUMMARY AVAILABLE FROM FDA COPENHAGEN, DENMARK DK-2740 DEVICE: MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALAN MEDTRONIC, INC. 510(k) NO: K984271(TRADITIONAL) ATTN: KAREN CROPPER PHONE NO : 714-779-3694 4633 EAST LA PALMA AVE. SE DECISION MADE: 09-MAR-99 ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS MEDTRONICS INTERVENTIONAL VASCULAR510(k) NO: K990707(SPECIAL) ATTN: MARK CHARTIER PHONE NO : 978-777-0042 37-A CHERRY HILL DR. SE DECISION MADE: 22-MAR-99 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DA METRON OPTICS, INC. 510(k) NO: K990264(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 31-MAR-99 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING MEXPO INTL., INC. 510(k) NO: K990210(TRADITIONAL) ATTN: TIM THAI PHONE NO : 510-293-6800 2671 MCCONE AVENUE SE DECISION MADE: 29-MAR-99 HAYWARD,, CA 94545 510(k) STATEMENT DEVICE: MICRINS MICRO ANASTOMOSIS CLAMP MICRINS MICROSURGICAL INSTRUMENTS,510(k) NO: K982278(TRADITIONAL) ATTN: BERNHARD TEITZ PHONE NO : 847-549-1410 28438 BALLARD DR. SE DECISION MADE: 26-MAR-99 LAKE FOREST, IL 60045 510(k) STATEMENT DEVICE: MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE MICRO-MEDICAL DEVICES, INC. 510(k) NO: K983882(TRADITIONAL) ATTN: JIM OHNECK PHONE NO : 216-229-8332 11000 CEDAR AVENUE SE DECISION MADE: 15-MAR-99 SUITE 445 510(k) SUMMARY AVAILABLE FROM FDA CLEVELAND, OH 44106 DEVICE: ACTIWATCH MINI-MITTER CO., INC. 510(k) NO: K983533(TRADITIONAL) ATTN: JACK E MCKENZIE PHONE NO : 541-593-8639 PO BOX 3386 SE DECISION MADE: 23-MAR-99 SUNRIVER, OR 97707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS MINNTECH CORP. 510(k) NO: K983126(TRADITIONAL) ATTN: MARK MURPHY PHONE NO : 612-551-2643 14905 28TH AVE. NORTH SE DECISION MADE: 08-MAR-99 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPERGEL 20% HYPERTONIC SALINE GEL MOLNLYCKE HEALTH CARE 510(k) NO: K984370(TRADITIONAL) ATTN: MIGUEL A NEGRON PHONE NO : 610-499-3383 500 BALDWIN TOWER SE DECISION MADE: 01-MAR-99 EDDYSTONE, PA 19022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEPITEL NON ADHERENT SILICONE DRESSING MOLNLYCKE HEALTH CARE 510(k) NO: K984371(TRADITIONAL) ATTN: MIGUEL A NEGRON PHONE NO : 610-499-3383 500 BALDWIN TOWER SE DECISION MADE: 03-MAR-99 EDDYSTONE, PA 19022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF MOSS P.E.G. TRAY MOSS TUBES, INC. 510(k) NO: K984628(TRADITIONAL) ATTN: HARRY SCHLAKMAN PHONE NO : 908-355-6032 304 VERONA AVENUE SE DECISION MADE: 17-MAR-99 ELIZABETH, NJ 07208 510(k) STATEMENT DEVICE: MOSS TUBES, INC. NASAL TUBE - MARK IV MOSS TUBES, INC. 510(k) NO: K984629(TRADITIONAL) ATTN: HARRY SCHLAKMAN PHONE NO : 908-355-6032 304 VERONA AVENUE SE DECISION MADE: 02-MAR-99 ELIZABETH, NJ 07208 510(k) STATEMENT DEVICE: MOSS GASTROSTOMY TUBE MOSS TUBES, INC. 510(k) NO: K990389(TRADITIONAL) ATTN: HARRY SCHLAKMAN PHONE NO : 908-355-6032 304 VERONA AVENUE SE DECISION MADE: 22-MAR-99 ELIZABETH, NJ 07208 510(k) STATEMENT DEVICE: BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 MURRAY ELECTRONICS 510(k) NO: K983228(TRADITIONAL) ATTN: KENT C HOFFMAN PHONE NO : 410-771-0380 260 SCHILLING CIRCLE SE DECISION MADE: 15-MAR-99 HUNT VALLEY, MD 21031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUZBEE MWR ELECTRONICS INDUSTRIAL CO. 510(k) NO: K982173(TRADITIONAL) ATTN: MANFRED W ROSCHER PHONE NO : 272 151 02653 21 ROSE RD. SE DECISION MADE: 11-MAR-99 GOODWOOD, CAPETOWN, SOUTH AFRICA 510(k) STATEMENT DEVICE: "TUTODROP 1" AND "TUTODROP 2" MYCO MEDICAL SUPPLIES, INC. 510(k) NO: K982098(TRADITIONAL) ATTN: SANJIV KUMAR PHONE NO : 919-678-0680 101 ROSE VALLEY WOODS DR. SE DECISION MADE: 01-MAR-99 CARY, NC 27513 510(k) STATEMENT DEVICE: TUTOPLUS IV ADMINISTRATION SET MYCO MEDICAL SUPPLIES, INC. 510(k) NO: K990388(TRADITIONAL) ATTN: SANJIV KUMAR PHONE NO : 919-678-0680 101 ROSE VALLEY WOODS DR. SE DECISION MADE: 29-MAR-99 CARY, NC 27513 510(k) STATEMENT DEVICE: PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE NAKANISHI, INC. 510(k) NO: K990646(TRADITIONAL) ATTN: HIROJI SEKIGUCHI PHONE NO : 028 964 3380 340 KAMIHINATA, KANUMA-SHI SE DECISION MADE: 19-MAR-99 TOCHIGI-KEN, JAPAN 322 510(k) STATEMENT DEVICE: PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), NAKANISHI, INC. 510(k) NO: K990682(TRADITIONAL) ATTN: HIROJI SEKIGUCHI PHONE NO : 012 896 3380 340 KAMIHINATA, KANUMA-SHI SE DECISION MADE: 24-MAR-99 TOCHIGI-KEN, JAPAN 322 510(k) STATEMENT DEVICE: BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES NAVION BIOMEDICAL CORP. 510(k) NO: K983476(TRADITIONAL) ATTN: DONALD A KAY PHONE NO : 781-341-8058 312 TOSCA DR. SE DECISION MADE: 01-MAR-99 STOUGHTON, MA 02072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESTORE (AKA RE/STOR) NEBL, INC. 510(k) NO: K983164(TRADITIONAL) ATTN: RAO NIMMAGADDA PHONE NO : 44 TERRACE DR. SE DECISION MADE: 05-MAR-99 WORCHESTER, MA 01609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROTUBE NEUROREGEN, L.L.C. 510(k) NO: K983007(TRADITIONAL) ATTN: JOHN E BARHAM PHONE NO : 410-838-8090 43 N. BONDS STREET SE DECISION MADE: 22-MAR-99 BEL AIR, MD 21014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCELSIOR PORCELAIN SYSTEM NEY DENTAL INC. 510(k) NO: K984427(TRADITIONAL) ATTN: ANDREW J PIETROBONO PHONE NO : 954-429-2886 1065 S.W. 30TH AVE. SE DECISION MADE: 15-MAR-99 DEERFIELD BEACH, FL 33442-8193 510(k) STATEMENT DEVICE: SYMBIOCERAM NEY DENTAL INC. 510(k) NO: K990629(TRADITIONAL) ATTN: ANDREW J PIETROBONO PHONE NO : 954-429-2886 1065 S.W. 30TH AVE. SE DECISION MADE: 19-MAR-99 DEERFIELD BEACH, FL 33442-8193 510(k) STATEMENT DEVICE: ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K980737(TRADITIONAL) ATTN: JIMMY WONG PHONE NO : 714-240-5260 33051 CALLE AVIADOR SE DECISION MADE: 23-MAR-99 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K981702(TRADITIONAL) ATTN: ROBERT D WAXHAM PHONE NO : 757-365-0978 222 INSTITUTE ST. SE DECISION MADE: 05-MAR-99 SMITHFIELD, VA 23430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVISIONAL DENTAL IMPLANT SYSTEM NOBEL BIOCARE USA, INC. 510(k) NO: K984287(TRADITIONAL) ATTN: JEFF HAUSHEER PHONE NO : 714-282-4800 22895 EASTPARK DRIVE SE DECISION MADE: 01-MAR-99 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DR180-R/OXY NORTHEAST MONITORING, INC. 510(k) NO: K983576(TRADITIONAL) ATTN: RODNEY L CAMBRE PHONE NO : 978-440-8348 730 BOSTON POST RD., SUITE 22 SE DECISION MADE: 23-MAR-99 SUDBURY, MA 01776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM OLYMPIC MEDICAL CORP. 510(k) NO: K983229(TRADITIONAL) ATTN: EDWARD (TED) B WEILER PHONE NO : 206-767-3500 5900 FIRST AVE., SOUTH SE DECISION MADE: 23-MAR-99 SEATTLE, WA 98108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS OLYMPUS OPTICAL, CO. 510(k) NO: K990687(TRADITIONAL) ATTN: LAURA STORMS TYLER PHONE NO : 516-844-5688 2 CORPORATE CENTER SE DECISION MADE: 26-MAR-99 MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) OPTI-CENTRE LABORATORIES 510(k) NO: K983496(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 29-MAR-99 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORBSCAN ORBTEK, INC. 510(k) NO: K984443(TRADITIONAL) ATTN: PIER CALACINO PHONE NO : 801-484-8777 3030 SOUTH MAIN ST., SUITE 600 SE DECISION MADE: 05-MAR-99 SALT LAKE CITY, UT 84115 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNOD ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K984289(TRADITIONAL) ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790 100 INDIGO CREEK DRIVE SE DECISION MADE: 12-MAR-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990531(TRADITIONAL) ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790 100 INDIGO CREEK DR. SE DECISION MADE: 12-MAR-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 I ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990783(TRADITIONAL) ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790 100 INDIGO CREEK DR. SE DECISION MADE: 25-MAR-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER OBL SB ANCHOR / SUTURE COMBINATION ORTHOPAEDIC BIOSYSTEMS, LTD. 510(k) NO: K982996(TRADITIONAL) ATTN: JEFFRY B SKIBA PHONE NO : 602-596-4066 15990 N GREENWAY-HAYDEN LOOP SE DECISION MADE: 04-MAR-99 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA SCOTTSDALE, AZ 85260 DEVICE: OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM OSTEONICS CORP. 510(k) NO: K982798(TRADITIONAL) ATTN: KATE SUTTON PHONE NO : 201-934-4386 59 ROUTE 17 SE DECISION MADE: 25-MAR-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. 510(k) NO: K984608(TRADITIONAL) ATTN: ANDY HOLLINGSWORTH PHONE NO : 441 256 841144 WADE RD. SE DECISION MADE: 09-MAR-99 BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) STATEMENT DEVICE: MACROPORE PROTECTIVE SHEET PACIFIC MATERIALS AND INTERFACES 510(k) NO: K983360(TRADITIONAL) ATTN: FLOYD G LARSON PHONE NO : 619-792-1235 4329 GRAYDON ROAD SE DECISION MADE: 19-MAR-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTSHEER LONG PULSE RUBY LASER PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K982980(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919-676-7166 9516 CANDOR OAKS DRIVE SE DECISION MADE: 04-MAR-99 RALEIGH, NC 27615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280 PANASONIC CORPORATION (PANASONIC) 510(k) NO: K981431(TRADITIONAL) ATTN: EDWARD M BASILE, ESQ. PHONE NO : 202-737-0500 1730 PENNSYLVANIA AVENUE N.W. SE DECISION MADE: 03-MAR-99 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284 PANASONIC CORPORATION (PANASONIC) 510(k) NO: K981542(TRADITIONAL) ATTN: EDWARD M BASILE PHONE NO : 202-737-0500 1730 PENNSYLVANIA AVENUE N.W. SE DECISION MADE: 03-MAR-99 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR PDG PRODUCT DESIGN GROUP, INC. 510(k) NO: K990557(TRADITIONAL) ATTN: PHIL MUNDY PHONE NO : 604 323 9220 9165 SHAUGHNESSY ST. SE DECISION MADE: 22-MAR-99 VANCOUVER, BC, CANADA V6P 6R9 510(k) STATEMENT DEVICE: PEREGRINE WET SET, MODEL PD400.00 PEREGRINE SURGICAL LTD. 510(k) NO: K990518(TRADITIONAL) ATTN: JOHN E RICHMOND PHONE NO : 215-348-0456 4050 D SKYRON DR. SE DECISION MADE: 25-MAR-99 DOYLESTOWN, PA 18901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATIO PHAMATECH 510(k) NO: K990249(TRADITIONAL) ATTN: CARL MONGIOVI PHONE NO : 619-635-5840 9265 ACTIVITY RD., #112-113 SE DECISION MADE: 22-MAR-99 SAN DIEGO, CA 92126 510(k) STATEMENT DEVICE: PHILIPS NICOL COLLIMATOR FAMILY PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K990423(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7031 710 BRIDGEPORT AVENUE SE DECISION MADE: 15-MAR-99 P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA SHELTON, CT 06484-4708 DEVICE: VIEWPOINT MICROSCOPE OPTION PICKER INTL., INC. 510(k) NO: K990860(SPECIAL) ATTN: ELAINE K KEELER PHONE NO : 440-473-5591 595 MINER RD. SE DECISION MADE: 30-MAR-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEWPOINT PASSIVE TOOL OPTION PICKER INTL., INC. 510(k) NO: K990868(SPECIAL) ATTN: ELAINE K KEELER PHONE NO : 440-473-5591 595 MINER RD. SE DECISION MADE: 30-MAR-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLUS FRACTURE HEAD PROSTHESIS PLUS ORTHOPEDICS 510(k) NO: K990309(TRADITIONAL) ATTN: HARTMUT LOCH PHONE NO : 619-455-2400 3550 GENERAL ATOMICS CT. SE DECISION MADE: 15-MAR-99 SAN DIEGO, CA 92121-1194 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGRAN HIP PROSTHESIS PONMED LTD. 510(k) NO: K984492(TRADITIONAL) ATTN: JEFFREY R SCHIDEMAN PHONE NO : 612-835-4018 7307 GLOUCHESTER DRIVE SE DECISION MADE: 15-MAR-99 EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X PRECISION BIOLOGIC 510(k) NO: K990296(TRADITIONAL) ATTN: SANDY MORRISON PHONE NO : 902 468 6422 900 WINDMILL RD., SUITE 100 SE DECISION MADE: 18-MAR-99 DARTMOUTH, N.S., CANADA B3B 1P7 510(k) STATEMENT DEVICE: THE.R.MO.FREE PRESSING NORTH AMERICA, INC. 510(k) NO: K990448(TRADITIONAL) ATTN: MARTIN A RIGUTTO PHONE NO : 888-340-2373 4311 S.W. RESEARCH WAY SE DECISION MADE: 23-MAR-99 CORVALLIS, OR 97333 510(k) STATEMENT DEVICE: ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/ PRINCETON BIOMEDITECH CORP. 510(k) NO: K990786(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. RT. 1 SE DECISION MADE: 26-MAR-99 MONMOUTH JUNCTION, NJ 08852-1905 510(k) STATEMENT DEVICE: NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATI PT. IRAMA DINAMIKA LATEX 510(k) NO: K984449(TRADITIONAL) ATTN: ANIL TANEJA PHONE NO : 62 061 515834 JL. KAPTEN PATTIMURA NO. 23/ SE DECISION MADE: 19-MAR-99 235 MEDAN 21053 510(k) STATEMENT INDONESIA, INDONESIA DEVICE: OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII RADIONICS SOFTWARE APPLICATIONS, I510(k) NO: K990326(SPECIAL) ATTN: KEVIN J O'CONNELL PHONE NO : 800-466-6814 22 TERRY AVE. SE DECISION MADE: 04-MAR-99 BURLINGTON, MA 01803-0658 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOL-TIP RF SYSTEM RADIONICS, INC. 510(k) NO: K984552(TRADITIONAL) ATTN: JEFFREY R MANNION PHONE NO : 800-466-6814 22 TERRY AVE. SE DECISION MADE: 05-MAR-99 BURLINGTON, MA 01803 510(k) STATEMENT DEVICE: RANDOX ALBUMIN RANDOX LABORATORIES LTD. 510(k) NO: K984494(TRADITIONAL) ATTN: P ARMSTRONG PHONE NO : 441 849 422413 ARDMORE, DIAMOND ROAD SE DECISION MADE: 23-MAR-99 CRUMLIN, CO. 510(k) STATEMENT ANTRIM BT29 4QY, UNITED KINGDOM BT29 4QY DEVICE: SPOROX II STERILIZING & DISINFECTING SOLUTION RECKITT & COLMAN, INC. 510(k) NO: K990703(SPECIAL) ATTN: SEAN MCNEAR PHONE NO : 973-686-7390 1655 VALLEY RD. SE DECISION MADE: 30-MAR-99 WAYNE, NJ 07474 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARIN RESOUND CORP. 510(k) NO: K984547(TRADITIONAL) ATTN: GARY ROESEL PHONE NO : 415-780-7800 220 SAGINAW DRIVE, SE DECISION MADE: 19-MAR-99 SEAPORT CENTRE 510(k) SUMMARY AVAILABLE FROM FDA REDWOOD CITY, CA 94063 DEVICE: BILICHEK NON-INVASIVE BILIRUBIN ANALYZER RESPIRONICS, INC. 510(k) NO: K983071(TRADITIONAL) ATTN: TIMOTHY Y COWART PHONE NO : 770-985-1498 3371 LENORA CHURCH RD SE DECISION MADE: 04-MAR-99 SNELLVILLE, GA 30039 510(k) STATEMENT DEVICE: RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563 RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K984521(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 17-MAR-99 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIE RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K984607(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 05-MAR-99 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706. RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K990050(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PARKWAY SE DECISION MADE: 26-MAR-99 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) ROCHE DIAGNOSTICS CORP. 510(k) NO: K990460(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 22-MAR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LC FLOWFILL S & C POLYMER GMBH 510(k) NO: K990108(TRADITIONAL) ATTN: JURGEN ENGELRECHT PHONE NO : 494 121 8619 ROBERT-BOSCH-STR. 5 SE DECISION MADE: 09-MAR-99 D-25335 510(k) SUMMARY AVAILABLE FROM FDA ELMSHORN, GERMANY DEVICE: SAS HCG SERUM CONTROLS SA SCIENTIFIC, INC. 510(k) NO: K990720(TRADITIONAL) ATTN: HARBI A SHADFAN PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 19-MAR-99 SAN ANTONIO, TX 78240 510(k) STATEMENT DEVICE: SAS HCG URINE CONTROLS SA SCIENTIFIC, INC. 510(k) NO: K990755(TRADITIONAL) ATTN: HARBI A SHADFAN PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 19-MAR-99 SAN ANTONIO, TX 78240 510(k) STATEMENT DEVICE: SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMP SABRATEK CORP. 510(k) NO: K983355(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-8169 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 12-MAR-99 HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 SCHIFF & CO. 510(k) NO: K982136(TRADITIONAL) ATTN: ANNE M CESARIO PHONE NO : 973-227-1830 1129 BLOOMFIELD AVENEU SE DECISION MADE: 24-MAR-99 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: FLEXISCOPE OPTOMODUL SCHOELLY FIBEROPTIC, GMBH 510(k) NO: K984641(TRADITIONAL) ATTN: JOSEPH RESS PHONE NO : 617-965-7714 45 PONTIAC ROAD SE DECISION MADE: 29-MAR-99 NEWTON, MA 02248 510(k) STATEMENT DEVICE: PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT SCIENCE INC. 510(k) NO: K990208(TRADITIONAL) ATTN: RALPH E HOGANCAMP PHONE NO : 612-835-1333 MINNESOTA CENTER, SUITE 1060 SE DECISION MADE: 25-MAR-99 7760 FRANCE AVENUE SOUTH 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, MN 55435-5803 DEVICE: ISOBAR SPINAL SYSTEM SCIENT'X 510(k) NO: K990118(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 22-MAR-99 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAIN CONTROL INFUSION PUMP SGARLATO LABORATORIES, INC. 510(k) NO: K990101(TRADITIONAL) ATTN: THOMAS SGARLATO PHONE NO : 408-399-4638 250 ALMENDRA AVENUE SE DECISION MADE: 19-MAR-99 LOS GATOS, CA 95030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K990267(TRADITIONAL) ATTN: DANNY WANG PHONE NO : 011 862 157727722 #1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 29-MAR-99 SONGJIANG SHANGHAI, CHINA 510(k) STATEMENT DEVICE: POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K990299(TRADITIONAL) ATTN: DANNY WANG PHONE NO : 011 862 157727722 #1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 29-MAR-99 SONGJIANG SHANGHAI, CHINA 510(k) STATEMENT DEVICE: 3D-ANGIO SIEMENS MEDICAL CORP. 510(k) NO: K984634(TRADITIONAL) ATTN: MALGORZATA STANEK PHONE NO : 732-321-3950 186 WOOD AVE. SO. SE DECISION MADE: 12-MAR-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMFAST SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K982952(TRADITIONAL) ATTN: KATHRYN B DODD PHONE NO : 925-602-8027 4040 NELSON AVE. SE DECISION MADE: 05-MAR-99 CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTI SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K990563(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 19-MAR-99 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPSY-DIGIT SITCO, INC. 510(k) NO: K990192(TRADITIONAL) ATTN: ROBERT H MCCARTHY PHONE NO : 847-463-2001 3456 N. RIDGE AVENUE #100 SE DECISION MADE: 12-MAR-99 ARLINGTON HEIGHTS, IL 60004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOJRAB MICRO-TORP, MODEL 7014-5845 SMITH & NEPHEW ENT. 510(k) NO: K990601(TRADITIONAL) ATTN: ALICIA FARAGE PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 31-MAR-99 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-THREADED ENDOBUTTON SMITH & NEPHEW, INC. 510(k) NO: K984550(TRADITIONAL) ATTN: SUSAN A FINNERAN PHONE NO : 508-261-3772 130 FORBES BLVD. SE DECISION MADE: 01-MAR-99 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGY CEMENTED HIP STEM SMITH & NEPHEW, INC. 510(k) NO: K990369(ABBREVIATED) ATTN: NEAL DEFIBAUGH PHONE NO : 901-399-5363 1450 BROOKS RD. SE DECISION MADE: 12-MAR-99 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH S SONIC INNOVATIONS INC. 510(k) NO: K984518(TRADITIONAL) ATTN: JEANNETTE S JOHNSON PHONE NO : 801-288-0993 5330 SOUTH 900 EAST, SUITE 240 SE DECISION MADE: 12-MAR-99 SALT LAKE CITY, UT 84117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C1 ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K990806(TRADITIONAL) ATTN: HOWARD HOLMAN PHONE NO : 425-487-7602 19807 NORTH CREEK PKWY., #200 SE DECISION MADE: 26-MAR-99 BOTHELL, WA 98011-8214 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL SOUTHLAND PRODUCTS CO., LTD. 510(k) NO: K990746(TRADITIONAL) ATTN: NG PENG LEONG PHONE NO : 006 674 342777 55 RAJYINDEE RD. SE DECISION MADE: 23-MAR-99 HATYAI SONGKHLA, THAILAND 90119 510(k) STATEMENT DEVICE: SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES SOUTHLAND PRODUCTS CO., LTD. 510(k) NO: K990751(TRADITIONAL) ATTN: NG PENG LEONG PHONE NO : 006 674 342777 55 RAJYINDEE RD. SE DECISION MADE: 23-MAR-99 HATYAI SONGKHLA, THAILAND 90119 510(k) STATEMENT DEVICE: SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) SPORICIDIN INTL. 510(k) NO: K983194(TRADITIONAL) ATTN: HAROLD E PLANK PHONE NO : 301-231-7700 5901 MONTROSE RD. SE DECISION MADE: 05-MAR-99 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANATOMICA GLENOID COMPONENT SULZER ORTHOPEDICS, INC. 510(k) NO: K990136(TRADITIONAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DR. SE DECISION MADE: 01-MAR-99 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K983790(TRADITIONAL) ATTN: MING SUN PHONE NO : 609-401-1080 604 VPR CENTER SE DECISION MADE: 01-MAR-99 1001 LOWER LANDING RD. 510(k) STATEMENT BLACKWOOD, NJ 08012 DEVICE: HEMOSLEEVE, MODEL 4.0MM, 5.5MM SURGICAL LASER TECHNOLOGIES, INC. 510(k) NO: K984018(TRADITIONAL) ATTN: MONICA FERRANTE PHONE NO : 215-619-3248 147 KEYSTONE DR. SE DECISION MADE: 15-MAR-99 MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIBOND SOLO PLUS SYBRON DENTAL SPECIALTIES,INC 510(k) NO: K990498(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 08-MAR-99 ORANGE, CA 92667 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MO SYNTEC-TAICHUNG MEDICAL INSTRUMENT510(k) NO: K984364(TRADITIONAL) ATTN: TED Y SHI PHONE NO : 886 479 87099 2, KUNG SAN ROAD, CHAUN SHING SE DECISION MADE: 02-MAR-99 INDUSTRIAL ZONE, SHEN KANG 510(k) SUMMARY AVAILABLE FROM FDA CHANG HUA, CHINA (TAIWAN) 509 DEVICE: SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUME SYNTEC-TAICHUNG MEDICAL INSTRUMENT510(k) NO: K984543(TRADITIONAL) ATTN: TED Y SHI PHONE NO : 886 479 87099 2, KUNG SAN ROAD, CHAUN SHING SE DECISION MADE: 01-MAR-99 INDUSTRIAL ZONE, SHEN KANG 510(k) SUMMARY AVAILABLE FROM FDA CHANG HUA, CHINA (TAIWAN) 509 DEVICE: SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM SYNTEC-TAICHUNG MEDICAL INSTRUMENT510(k) NO: K984602(TRADITIONAL) ATTN: TED Y SHI PHONE NO : 886 479 8099 2, KUNG SAN ROAD, CHAUN SHING SE DECISION MADE: 05-MAR-99 INDUSTRIAL ZONE, SHEN KANG 510(k) SUMMARY AVAILABLE FROM FDA CHANG HUA, CHINA (TAIWAN) 509 DEVICE: MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM SYNTHES SPINE 510(k) NO: K990745(SPECIAL) ATTN: J0NATHAN GILBERT PHONE NO : 610-647-9700 P.O. BOX 0548 SE DECISION MADE: 30-MAR-99 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: ACCU GUIDE TAYMAN MEDICAL, INC. 510(k) NO: K984382(TRADITIONAL) ATTN: VAUGHN WEEKS PHONE NO : 414-632-0355 621 16TH STREET SE DECISION MADE: 05-MAR-99 RACINE, WI 53403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURAL BRAND ACUPUNCTURE NEEDLES TCM SUPPLY CORP. 510(k) NO: K983671(TRADITIONAL) ATTN: WILLIAM HUNG LEE PHONE NO : 909-628-9698 12490 CENTRAL AVE., SUITE 221 SE DECISION MADE: 04-MAR-99 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISPORT X AND TISPORT XC TISPORT 510(k) NO: K990555(TRADITIONAL) ATTN: SANDRA GLADSTONE PHONE NO : 509-586-6117 1426 EAST THIRD AVENUE SE DECISION MADE: 22-MAR-99 KENNEWICK, WA 99337 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILI TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K990134(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR./P.O. BOX SE DECISION MADE: 19-MAR-99 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92680-2068 DEVICE: SSA-320A JUST VISION 200/ SSA-325A JUST VISION TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K990490(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR./P.O. BOX SE DECISION MADE: 02-MAR-99 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92680-2068 DEVICE: ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM TRANSFUSION TECHNOLOGIES CORP. 510(k) NO: K982660(TRADITIONAL) ATTN: JOHN J SOKOLOWSKI PHONE NO : 508-655-2277 9 ERIE DR. SE DECISION MADE: 30-MAR-99 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSHEATH VISION SCIENCES, INC. 510(k) NO: K990354(SPECIAL) ATTN: PAMELA PAPINEAU PHONE NO : 9 STRATHMORE ROAD SE DECISION MADE: 31-MAR-99 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VNUS CLOSURE SYSTEM VNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K982816(TRADITIONAL) ATTN: JOHN D'ANGELO PHONE NO : 408-747-1200 238 EAST CARIBBEAN DR. SE DECISION MADE: 17-MAR-99 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECLUDE ACUSEAL DURA SUBSTITUTE W.L. GORE & ASSOC., INC. 510(k) NO: K984534(TRADITIONAL) ATTN: JOHN NICHOLSON PHONE NO : 520-779-2771 3750 WEST KILTIE LN. SE DECISION MADE: 15-MAR-99 FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAKO AUTOKIT LP(A) WAKO CHEMICALS, USA, INC. 510(k) NO: K981446(TRADITIONAL) ATTN: TONYA MALLORY PHONE NO : 800-992-9256 1600 BELLWOOD RD. SE DECISION MADE: 09-MAR-99 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: `THE INSEMINATOR' (PROPOSED) WALLACH SURGICAL DEVICES, INC. 510(k) NO: K984306(TRADITIONAL) ATTN: MICHAEL MALIS PHONE NO : 203-799-2000 235 EDISON RD. SE DECISION MADE: 01-MAR-99 ORANGE, CT 06477 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) WEMBLEY RUBBER PRODUCTS (M) SDN BH510(k) NO: K982600(TRADITIONAL) ATTN: CHOW YUE WAH PHONE NO : 011 603 8461486 PERU BANDAR BARU SALAK TINGGI SE DECISION MADE: 12-MAR-99 43900 SEPANG 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR, MALAYSIA, MALAYSIA DEVICE: WILSON-COOK BIPOLAR PROBE WILSON-COOK MEDICAL, INC. 510(k) NO: K990145(TRADITIONAL) ATTN: PAULA JOYCE PHONE NO : 910-744-0157 4900 BETHANIA STATION RD. SE DECISION MADE: 25-MAR-99 WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESOPHAGEAL INTUBATION DETECTOR WOLFE TORY MEDICAL, INC. 510(k) NO: K990556(TRADITIONAL) ATTN: TIM WOLFE PHONE NO : 801-281-3000 79 WEST 4500 SOUTH, SUITE 21 SE DECISION MADE: 26-MAR-99 SALT LAKE CITY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITANIUM VERSALOK WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K990708(SPECIAL) ATTN: DAN REGAN PHONE NO : 800-238-7188 5677 AIRLINE RD. SE DECISION MADE: 30-MAR-99 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSOM CARD PREGNANCY TEST, MODEL 103 WYNTEK DIAGNOSTICS, INC. 510(k) NO: K990576(TRADITIONAL) ATTN: SHU-CHING CHENG PHONE NO : 619-452-3198 6146 NANCY RIDGE DR., SE DECISION MADE: 09-MAR-99 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: OSOM CARD II HCG-URINE TEST, MODEL 102 WYNTEK DIAGNOSTICS, INC. 510(k) NO: K990578(TRADITIONAL) ATTN: SHU-CHING CHENG PHONE NO : 619-452-3198 6146 NANCY RIDGE DR., SE DECISION MADE: 09-MAR-99 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION G YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K990013(TRADITIONAL) ATTN: E J SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 23-MAR-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K983656(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 18-MAR-99 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY EL ZEUS SCIENTIFIC, INC. 510(k) NO: K984138(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 23-MAR-99 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: GLIADIN IGA ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K990207(TRADITIONAL) ATTN: MARK K KOPNITSKY PHONE NO : 908-526-3744 P.O. BOX 38 SE DECISION MADE: 26-MAR-99 RARITAN, NJ 08869 510(k) STATEMENT DEVICE: ZOLL M SERIES SPO2 OPTION ZOLL MEDICAL CORP. 510(k) NO: K982992(TRADITIONAL) ATTN: MAURA MCGUIRE PHONE NO : 800-242-9150 32 SECOND AVE. SE DECISION MADE: 11-MAR-99 BURLINGTON, MA 01803 510(k) STATEMENT DEVICE: VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODI ZYMETX, INC. 510(k) NO: K984596(TRADITIONAL) ATTN: CRAIG D SHIMASAKI PHONE NO : 405-271-1314 800 RESEARCH PKWY., SUITE 100 SE DECISION MADE: 04-MAR-99 OKLAHOMA CITY, OK 73104 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 296 TOTAL WITH SUMMARIES 190 TOTAL WITH STATEMENTS 106
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