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Medical Devices
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October 1999 510(k) Clearances
DEVICE: 3M CLINPRO SEALANT 3M CO. 510(k) NO: K992326(TRADITIONAL) ATTN: LAEL J PICKETT PHONE NO : 651-733-3594 3M CENTER, BLDG. 260-2B-12 SE DECISION MADE: 08-OCT-99 ST. PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO SODIUM TEST SYSTEM ABAXIS INC. 510(k) NO: K993211(TRADITIONAL) ATTN: LISA MCGRATH PHONE NO : 408-745-6550 1320 CHESAPEAKE TERR. SE DECISION MADE: 25-OCT-99 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT AXSYM HOMOCYSTEINE ABBOTT LABORATORIES, INC. 510(k) NO: K992858(TRADITIONAL) ATTN: MARGARET PROCHNIAK PHONE NO : 847-937-4106 DEPT 9YC, BIDG. AP31 SE DECISION MADE: 25-OCT-99 200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA ABBOTT PARK, IL 60064-6200 DEVICE: ALCYON 300I (WITH ISE MODULE) ANALYZER ABBOTT LABORATORIES, INC. 510(k) NO: K993083(SPECIAL) ATTN: MARK LITTLEFIELD PHONE NO : 972-518-6062 1920 HURD SE DECISION MADE: 05-OCT-99 IRVING, TX 75062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABX PENTRA 60 HEMATOLOGY ANALYZER ABX DIAGNOSTICS, INC. 510(k) NO: K992511(TRADITIONAL) ATTN: PAT AMTOWER PHONE NO : 949-453-0500 34 BUNSEN DR. SE DECISION MADE: 15-OCT-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 ACCUTRON, INC. 510(k) NO: K992421(SPECIAL) ATTN: DOTTIE KNECHTEL PHONE NO : 602-780-2020 2020 WEST MELINDA LANE SE DECISION MADE: 27-OCT-99 PHOENIX, AZ 85027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACON COMBO PREGNANCY ACON LABORATORIES, INC. 510(k) NO: K993065(TRADITIONAL) ATTN: JIXUN LIN PHONE NO : 858-535-2035 11175 FLINTKOTE AVE., #F & G SE DECISION MADE: 08-OCT-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FETAL ASSESSMENT CAP ACUSON CORP. 510(k) NO: K992580(TRADITIONAL) ATTN: WILLIAM E WELCH PHONE NO : 004 989 32475830 1220 CHARLESTON RD. SE DECISION MADE: 18-OCT-99 MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION ADAC LABORATORIES 510(k) NO: K992317(TRADITIONAL) ATTN: DENNIS W HENKELMAN PHONE NO : 408-468-3989 540 ALDER DR. SE DECISION MADE: 01-OCT-99 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE ADVANCED CARDIOVASCULAR SYSTEMS, I510(k) NO: K992169(TRADITIONAL) ATTN: MARGARET ANDERSON PHONE NO : 408-235-3995 3200 LAKESIDE DRIVE SE DECISION MADE: 28-OCT-99 SANTA CLARA, CA 95052-8167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHA INFUSION PUMP ADVANCED INFUSION, INC. 510(k) NO: K992551(TRADITIONAL) ATTN: JAMES CHRISTENSEN PHONE NO : 480-557-7337 6200 SOUTH MCCLINTOCK #6 SE DECISION MADE: 27-OCT-99 TEMPE, AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIDEX OPA SOLUTION ADVANCED STERILIZATION PRODUCTS 510(k) NO: K991487(TRADITIONAL) ATTN: JOHN E FRIND PHONE NO : 949-789-3885 33 TECHNOLOGY DRIVE SE DECISION MADE: 08-OCT-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MCL 29 DERMABLATE ER:YAG LASER SYSTEM AESCULAP-MEDITEC NORTH AMERICA 510(k) NO: K992707(TRADITIONAL) ATTN: WILLIAM KELLEY PHONE NO : 949-660-2950 2525 MCGAW AVE. SE DECISION MADE: 19-OCT-99 IRVINE, CA 92623-9791 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCAT ALBA CRITICAL CARE LTD 510(k) NO: K993245(SPECIAL) ATTN: TED VANDER WIEDE PHONE NO : 169 874 6699 PHOENIX CRESCENT SE DECISION MADE: 28-OCT-99 STRATHCLYDE BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA BELLSHILL, UNITED KINGDOM ML4 3NJ DEVICE: BROWNE CIDEX OPA INDICATOR ALBERT BROWNE LTD. 510(k) NO: K991709(TRADITIONAL) ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207 49 PLAIN STREET SE DECISION MADE: 08-OCT-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CO ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991205(TRADITIONAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKEGAN RD. SE DECISION MADE: 13-OCT-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFRESH CONTACTS LUBRICATING AND REWETTING DROPS ALLERGAN, INC. 510(k) NO: K992028(ABBREVIATED) ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761 2525 DUPONT DR. SE DECISION MADE: 07-OCT-99 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CON ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K992870(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 600 459 32235 LOT 2716&2720, MK 7, KAWASAN SE DECISION MADE: 15-OCT-99 PERINDUSTRIAN BUKIT PANCHOR 510(k) STATEMENT NINONG TEBAL, PULAU PINANG, MALAYSIA 14300 DEVICE: AMBU HAND POWER SUCTION PUMP AMBU, INC. 510(k) NO: K992902(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410-636-1144 611 NORTH HAMMONDS FERRY RD. SE DECISION MADE: 25-OCT-99 LINTHICUM, MD 21090-1356 510(k) STATEMENT DEVICE: RAPIDONE-AMPHETAMINE TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K992452(TRADITIONAL) ATTN: JOHN B DUBECK PHONE NO : 202-434-4125 1001 G STREET, NW SE DECISION MADE: 18-OCT-99 SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20001 DEVICE: AMIGO MODEL 680000 (AMIGO EXCITE F 350) AMIGO MOBILITY INTL., INC. 510(k) NO: K992619(TRADITIONAL) ATTN: DALE CONFER PHONE NO : 517-777-0910 6693 DIXIE HWY. SE DECISION MADE: 25-OCT-99 BRIDGEPORT, MI 48722 510(k) STATEMENT DEVICE: 50 W METAL HALIDE ILLUMINATOR, VES 0501. ANGIOLAZ, INC. 510(k) NO: K992447(TRADITIONAL) ATTN: JOHN PLUMADORE PHONE NO : 802-463-9976 INDUSTRIAL PARK SE DECISION MADE: 20-OCT-99 BELLOWS FALLS, VT 05101-0556 510(k) STATEMENT DEVICE: SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMIN ANSELL PERRY INC. 510(k) NO: K992156(TRADITIONAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, S.E. SE DECISION MADE: 27-OCT-99 MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOV ANSELL PERRY INC. 510(k) NO: K992768(TRADITIONAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, S.E. SE DECISION MADE: 13-OCT-99 MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PRO ANSELL PERRY INC. 510(k) NO: K992953(TRADITIONAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, S.E. SE DECISION MADE: 29-OCT-99 MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTA GRAFT (<6MM) ATRIUM MEDICAL CORP. 510(k) NO: K992958(SPECIAL) ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 01-OCT-99 HUDSON, NH 03051 510(k) STATEMENT DEVICE: ADVANTA GRAFT (>6MM) ATRIUM MEDICAL CORP. 510(k) NO: K992960(SPECIAL) ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 01-OCT-99 HUDSON, NH 03051 510(k) STATEMENT DEVICE: NEO-2 METER AUTOMATA INSTRUMENTATION, INC. 510(k) NO: K992431(TRADITIONAL) ATTN: LINDA V MASANO PHONE NO : 480-998-8422 15600 NORTH 78TH ST. SE DECISION MADE: 13-OCT-99 SCOTTSDALE, AZ 85260-1735 510(k) STATEMENT DEVICE: MODIFICATION TO IMX HOMOCYSTEINE AXIS BIOCHEMICALS, ASA 510(k) NO: K992274(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751 PO BOX 262069 SE DECISION MADE: 06-OCT-99 SAN DIEGO, CA 92196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER AZO ENTERPRISES 510(k) NO: K992435(TRADITIONAL) ATTN: NABIL AZO PHONE NO : 6114 NORTH SACRAMENTO SE DECISION MADE: 15-OCT-99 CHICAGO, IL 60659 510(k) STATEMENT DEVICE: BALLARD MIC-KEY "G" LOW PROFILE GASTROSTOMY REPLACEMENT KIT BALLARD MEDICAL PRODUCTS 510(k) NO: K993138(SPECIAL) ATTN: E. MARTIN CHAMBERLAIN PHONE NO : 801-572-6800 12050 S. LONE PEAK PKWY. SE DECISION MADE: 20-OCT-99 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 0.9% SODIUM CHLORIDE FLUSH SYRINGE BAXTER HEALTHCARE CORP. 510(k) NO: K984590(TRADITIONAL) ATTN: MARCIA MARCONI PHONE NO : 847-270-4637 CLINTEC NUTRITION CO. SE DECISION MADE: 07-OCT-99 ROUTE 120 AND WILSON ROAD 510(k) SUMMARY AVAILABLE FROM FDA ROUND LAKE, IL 60073 DEVICE: T-ANASTAFLO BAXTER RESEARCH MEDICAL, INC. 510(k) NO: K990396(TRADITIONAL) ATTN: JOHN W SMITH PHONE NO : 801-565-6213 6864 SOUTH 300 WEST SE DECISION MADE: 01-OCT-99 MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BECTON DICKINSON SYRINGE BECTON DICKINSON & CO. 510(k) NO: K992734(TRADITIONAL) ATTN: GREG MORGAN PHONE NO : 201-847-4344 1 BECTON DRIVE, BLDG 2, SE DECISION MADE: 01-OCT-99 MAIL CODE 226 510(k) SUMMARY AVAILABLE FROM FDA FRANKLIN LAKES, NJ 07417 DEVICE: EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS BENZ RESEARCH AND DEVELOPMENT CORP510(k) NO: K992692(TRADITIONAL) ATTN: JOSE A ORS PHONE NO : 941-758-8256 P.O. BOX 1839 SE DECISION MADE: 18-OCT-99 SARASOTA, FL 34230-1839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENT KNEE SYSTEM BIOMET MANUFACTURING, INC. 510(k) NO: K993111(SPECIAL) ATTN: MARY VERSTYNEN PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 05-OCT-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS BIOMET, INC. 510(k) NO: K992899(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 21-OCT-99 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BONE MULCH SCREW SYSTEM BIOMET, INC. 510(k) NO: K993025(SPECIAL) ATTN: FRED MCCLURE PHONE NO : 210-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 08-OCT-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MAXIM KNEE SYSTEM BIOMET, INC. 510(k) NO: K993159(SPECIAL) ATTN: TRACY J BICKEL PHONE NO : 219-372-1761 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 14-OCT-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: SEALOUETTE FIBRIN SEALANT APPLICATOR BIOSURGICAL CORP. 510(k) NO: K992351(TRADITIONAL) ATTN: TERRY E LAAS PHONE NO : 925-737-1850 5990 STONERIDGE AVE SE DECISION MADE: 08-OCT-99 SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94588 DEVICE: ILLUSION BISCO, INC. 510(k) NO: K993192(TRADITIONAL) ATTN: KATHEYN B PATTERSON PHONE NO : 847-534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 27-OCT-99 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRODUCER SHEATH, VESSEL DILATOR BOSTON SCIENTIFIC CORP. 510(k) NO: K992309(TRADITIONAL) ATTN: SUSAN POOL PHONE NO : 408-895-3608 2710 ORCHARD PARKWAY SE DECISION MADE: 07-OCT-99 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LINER II: SOFT RELINE LIQUID BOSWORTH CO. 510(k) NO: K991687(TRADITIONAL) ATTN: MILDRED M GOLDSTEIN PHONE NO : 708-679-3400 7227 NORTH HAMLIN AVENUE SE DECISION MADE: 07-OCT-99 SKOKIE, IL 60076-3999 510(k) STATEMENT DEVICE: BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER BRAUN GMBH 510(k) NO: K992468(TRADITIONAL) ATTN: LAURA GUY PHONE NO : 858-458-2290 10421 PACIFIC CENTER COURT SE DECISION MADE: 20-OCT-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM BRIGHT MEDICAL INSTRUMENTS 510(k) NO: K992898(TRADITIONAL) ATTN: ROBERT E SIMONSON PHONE NO : 877-527-4448 799 N.E. 71ST STREET SE DECISION MADE: 21-OCT-99 BOCA RATON, FL 33487 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIDEO PLUS SYSTEM, SERIES 95000 CAMTRONICS, LTD. 510(k) NO: K992666(TRADITIONAL) ATTN: ROBERT KRIEDERMANN PHONE NO : 414-367-0700 MEDICAL SYSTEMS SE DECISION MADE: 13-OCT-99 900 WALNUT RIDGE DR. 510(k) SUMMARY AVAILABLE FROM FDA HARTLAND, WI 53029 DEVICE: CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 CANON U.S.A. INC. 510(k) NO: K992547(TRADITIONAL) ATTN: KEN SHADOFF PHONE NO : 516-328-5602 ONE CANON PLAZA SE DECISION MADE: 13-OCT-99 LAKE SUCCESS, NY 11042-1113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG MINIMONITOR, MODEL CG-5000 CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K992696(TRADITIONAL) ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600 2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 07-OCT-99 REHOVOT, ISRAEL 76100 510(k) STATEMENT DEVICE: CATHETER INNOVATIONS IMPLANTABLE PORT CATHETER INNOVATIONS, INC. 510(k) NO: K991897(TRADITIONAL) ATTN: ROGER L RICHINS PHONE NO : 801-954-8444 3598 WEST 1820 SOUTH SE DECISION MADE: 21-OCT-99 SALT LAKE CITY, UT 84104-4859 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D/SENSE II (GREEN-OR) DENTIN DESENSITIZER CENTRIX INC. 510(k) NO: K992629(TRADITIONAL) ATTN: JOHN DISCKO PHONE NO : 203-929-5582 770 RIVER ROAD SE DECISION MADE: 22-OCT-99 SHELTON, CT 06484-5458 510(k) STATEMENT DEVICE: CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 CERAMOPTEC, INC. 510(k) NO: K993002(TRADITIONAL) ATTN: CAROL J MORELLO PHONE NO : 413-525-0600 515 SHAKER ROAD SE DECISION MADE: 14-OCT-99 EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM CIRCON CORP. 510(k) NO: K992544(TRADITIONAL) ATTN: RONALD J EHMSEN PHONE NO : 805-961-3290 6500 HOLLISTER AVENUE SE DECISION MADE: 26-OCT-99 SANTA BARBARA, CA 93117-3019 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR COBE CARDIOVASCULAR, INC. 510(k) NO: K991452(TRADITIONAL) ATTN: LYNNE LEONARD PHONE NO : 303-467-6586 14401 WEST 65TH WAY SE DECISION MADE: 07-OCT-99 ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS CODMAN & SHURTLEFF, INC. 510(k) NO: K992591(TRADITIONAL) ATTN: JAMES M FLAHERTY PHONE NO : 508-880-8404 325 PARAMOUNT DRIVE SE DECISION MADE: 15-OCT-99 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUBULAR ELECTRODE DEVICE CONWAY STUART MEDICAL, INC. 510(k) NO: K992542(TRADITIONAL) ATTN: THOMAS WEHMAN PHONE NO : 408-733-9910 735 PALOMAR ST. SE DECISION MADE: 27-OCT-99 SUNNYVALE, CA 94086 510(k) STATEMENT DEVICE: COOK ULTRA QUIET VACUUM PUMP & REGULATOR COOK UROLOGICAL, INC. 510(k) NO: K992070(TRADITIONAL) ATTN: BRENDA DAVIS PHONE NO : 812-829-6500 1100 WEST MORGAN ST. SE DECISION MADE: 27-OCT-99 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MAR CORDIS CORP. 510(k) NO: K992347(TRADITIONAL) ATTN: KAREN WILK PHONE NO : 908-412-7257 40 TECHNOLOGY DRIVE SE DECISION MADE: 08-OCT-99 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTA BRITE TIP CATHETERS CORDIS CORP. 510(k) NO: K992673(TRADITIONAL) ATTN: DENNIS S GRIFFIN PHONE NO : 305-824-5283 14201 N.W. 60TH AVE. SE DECISION MADE: 12-OCT-99 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALMAZ XL TANSHEPATIC BILIARY STENTS CORDIS CORP. 510(k) NO: K993091(SPECIAL) ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332 14201 N.W. 60TH AVE. SE DECISION MADE: 29-OCT-99 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROWLER PLUS INFUSION CATHETER CORDIS ENDOVASCULAR SYSTEMS, INC. 510(k) NO: K993266(SPECIAL) ATTN: MARITZA CELAYA PHONE NO : 305-512-6546 14000 N.W. 57TH CT. SE DECISION MADE: 28-OCT-99 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 CORDIS WEBSTER, INC. 510(k) NO: K991531(TRADITIONAL) ATTN: MARY ADAMS PHONE NO : 626-939-8604 4750 LITTLEJOHN ST. SE DECISION MADE: 04-OCT-99 BALDWIN PARK, CA 91706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DADE BEHRING N HIGH SENSITIVITY CRP ASSAY DADE BEHRING, INC. 510(k) NO: K991385(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 P.O. BOX 6101 SE DECISION MADE: 25-OCT-99 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAIWA MODEL 180 DAIWA PRODUCTS, INC. 510(k) NO: K983616(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 15-OCT-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 DATA MEDICAL ASSOCIATES, INC. 510(k) NO: K993098(TRADITIONAL) ATTN: THOMAS G DOLLAR PHONE NO : 817-640-0965 845 AVENUE "G" EAST SE DECISION MADE: 08-OCT-99 ARLINGTON, TX 76011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NRC NON-RINSE CONDITIONER DENTSPLY INTL. 510(k) NO: K992519(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 22-OCT-99 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUCITONE FRS FLEXIBEL DENTAL RESIN DENTSPLY INTL. 510(k) NO: K992956(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 06-OCT-99 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER DEROYAL CARDIOVASCULAR, INC. 510(k) NO: K993089(TRADITIONAL) ATTN: LOIS MARSH PHONE NO : 423-938-7828 200 DEBUSK LANE SE DECISION MADE: 14-OCT-99 POWELL, TN 37849 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K993178(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 18-OCT-99 WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT CHARLOTTETOWN, P.E.I., CANADA C1E 2A6 DEVICE: DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM DIAMEDIX CORP. 510(k) NO: K993294(TRADITIONAL) ATTN: LYNNE STIRLING, PH.D PHONE NO : 305-324-2354 2140 NORTH MIAMI AVE. SE DECISION MADE: 25-OCT-99 MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHELLY PROTECTED AV FISTULA NEEDLE DIASOL INC. 510(k) NO: K992653(TRADITIONAL) ATTN: MONICA ABELES PHONE NO : 818-255-1800 13212 RAYMER ST. SE DECISION MADE: 27-OCT-99 NORTH HOLLYWOOD, CA 91605 510(k) STATEMENT DEVICE: DRYASOL ACID CONCENTRATE MIX DIASOL INC. 510(k) NO: K993212(SPECIAL) ATTN: MONICA ABELES PHONE NO : 818-255-1800 13212 RAYMER ST. SE DECISION MADE: 22-OCT-99 NORTH HOLLYWOOD, CA 91605 510(k) STATEMENT DEVICE: HYBRID CAPTURE II CT-ID TEST DIGENE CORP. 510(k) NO: K990023(TRADITIONAL) ATTN: MARK DEL VECCHIO PHONE NO : 301-470-6500 9000 VIRGINIA MANOR RD., SE DECISION MADE: 25-OCT-99 BELTSVILLE, MD 20705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY DR. FRITZ GMBH 510(k) NO: K990372(TRADITIONAL) ATTN: JAMES CHITTY PHONE NO : 310-263-4150 13311 BROOKS DRIVE, SUITE E SE DECISION MADE: 14-OCT-99 BALDWIN PARK, CA 91706 510(k) STATEMENT DEVICE: HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRA ELAN HOLDINGS, INC. 510(k) NO: K992845(TRADITIONAL) ATTN: WYNN STOCKING PHONE NO : 714-871-8360 231 NORTH PUENTE ST. SE DECISION MADE: 18-OCT-99 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HICHEM TOTAL PROTEIN REAGENT ELAN HOLDINGS, INC. 510(k) NO: K992846(TRADITIONAL) ATTN: WYNN STOCKING PHONE NO : 714-871-8360 231 NORTH PUENTE ST. SE DECISION MADE: 18-OCT-99 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HICHEM BUN REAGENT ELAN HOLDINGS, INC. 510(k) NO: K992847(TRADITIONAL) ATTN: WYNN STOCKING PHONE NO : 714-871-8360 231 NORTH PUENTE ST. SE DECISION MADE: 14-OCT-99 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRIC MOBILITY "CAVALIER SCOOTERS" ELECTRIC MOBILITY CORP. 510(k) NO: K991281(TRADITIONAL) ATTN: MARK HOSKIN PHONE NO : 609-468-0270 1 MOBILITY PLAZA SE DECISION MADE: 27-OCT-99 SEWELL, NJ 08080 510(k) STATEMENT DEVICE: AIRFLOW HANDY ELECTRO MEDICAL SYSTEMS, INC. 510(k) NO: K991857(TRADITIONAL) ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 07-OCT-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI OMEGA 21 SYSTEM ELECTRO-BIOLOGY, INC. 510(k) NO: K992333(TRADITIONAL) ATTN: JONAS WILF PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 08-OCT-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGITRON RADIOLASE ELLMAN INTL., INC. 510(k) NO: K992382(TRADITIONAL) ATTN: FRANK LIN PHONE NO : 516-569-1482 1135 RAILROAD AVE., SE DECISION MADE: 14-OCT-99 ELLMAN BLDG. 510(k) SUMMARY AVAILABLE FROM FDA HEWLETT, NY 11557 DEVICE: EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTE EMORY UNIVERSITY 510(k) NO: K992450(TRADITIONAL) ATTN: ERNEST V GARCIA PHONE NO : 404-712-7422 1364 CLIFTON RD. N.E. SE DECISION MADE: 07-OCT-99 RM. E163 510(k) SUMMARY AVAILABLE FROM FDA ATLANTA, GA 30322 DEVICE: DUAL LUMEN CATHETER, MODEL DL-35-90 ENDOLOGIX, INC. 510(k) NO: K991601(TRADITIONAL) ATTN: KAREN U SALINAS PHONE NO : 949-830-9433 20 FAIRBANKS, SUITE #173 SE DECISION MADE: 28-OCT-99 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT ENDOTEC, INC. 510(k) NO: K992394(TRADITIONAL) ATTN: JOHN PAPPAS PHONE NO : 973-762-0095 20 VALLEY STREET SE DECISION MADE: 15-OCT-99 SOUTH ORANGE, NJ 07079 510(k) STATEMENT DEVICE: ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103 ERBE USA, INC. 510(k) NO: K992764(TRADITIONAL) ATTN: SCOTT CUNDY PHONE NO : 770-955-4400 2225 NORTHWEST PKWY., STE. 105 SE DECISION MADE: 14-OCT-99 MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20 ERBE USA, INC. 510(k) NO: K992769(TRADITIONAL) ATTN: SCOTT CUNDY PHONE NO : 770-955-4400 2225 NORTHWEST PKWY., STE. 105 SE DECISION MADE: 14-OCT-99 MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYCONALPHA WITH OPTION ECG ERICH JAEGER B.V. 510(k) NO: K984465(TRADITIONAL) ATTN: LEON DEN BAKKER PHONE NO : 030-659-4600 REGULIERENING 11 SE DECISION MADE: 27-OCT-99 NL-3981 LA BUNNIK, NETHERLANDS NL-510(k) STATEMENT DEVICE: REFERENCE ESPE DENTAL AG 510(k) NO: K992966(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 07-OCT-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, ETHICON ENDO-SURGERY, INC. 510(k) NO: K992612(TRADITIONAL) ATTN: EDWIN O BILLIPS PHONE NO : 513-786-7162 4545 CREEK RD. SE DECISION MADE: 14-OCT-99 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URETERO-RENOSCOPE FIBER IMAGING TECHNOLOGIES, INC. 510(k) NO: K992527(TRADITIONAL) ATTN: JOSEPH RESS PHONE NO : 617-965-7714 45 PONTIAC ROAD SE DECISION MADE: 13-OCT-99 NEWTON, MA 02468 510(k) STATEMENT DEVICE: FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNI FUKUDA DENSHI USA, INC. 510(k) NO: K990401(TRADITIONAL) ATTN: DAVID J GERAGHTY PHONE NO : 425-881-7737 55 NORTHERN BLVD., SUITE 410 SE DECISION MADE: 15-OCT-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) GAMBRO RENAL CARE PRODUCTS 510(k) NO: K993064(SPECIAL) ATTN: WILLIAM M TOWNSEND PHONE NO : 303-231-4730 1185 OAK ST. SE DECISION MADE: 06-OCT-99 LAKEWOOD, CO 80215-4498 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CASE 8000 EXERCISE TESTING SYSTEM GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991014(TRADITIONAL) ATTN: LAURA L MCCOMIS PHONE NO : 414-362-2688 8200 WEST TOWER AVE. SE DECISION MADE: 20-OCT-99 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILHOUETTE FC GE MEDICAL SYSTEMS, INC. 510(k) NO: K993090(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 414-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 01-OCT-99 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANEROID SPHYGMOMANOMETER GENMED, INC. 510(k) NO: K990638(ABBREVIATED) ATTN: EDWARD HYER PHONE NO : 410-354-3300 914 WEST PATAPSCO AVE. SE DECISION MADE: 07-OCT-99 BALTIMORE, MD 21230-3432 510(k) STATEMENT DEVICE: N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTER GENZYME CORP. 510(k) NO: K992766(TRADITIONAL) ATTN: BARBARA PIZZA PHONE NO : 617-252-7953 ONE KENDALL SQUARE SE DECISION MADE: 18-OCT-99 CAMBRIDGE, MA 02139-1562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENZYME DIRECT AMYLASE VERIFIER GENZYME CORP. 510(k) NO: K993132(ABBREVIATED) ATTN: BARBARA PIZZA PHONE NO : 617-252-7953 ONE KENDALL SQUARE SE DECISION MADE: 04-OCT-99 CAMBRIDGE, MA 02139-1562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECOMED SCALP VEIN SET GREINER MEDITECH, INC. 510(k) NO: K992145(TRADITIONAL) ATTN: DOUGLAS L HARRIS PHONE NO : 410-836-8228 260 GATEWAY DR., SUITE 17A SE DECISION MADE: 14-OCT-99 BEL AIR, MD 21014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY S GUIDANT CORP. 510(k) NO: K992319(TRADITIONAL) ATTN: SANDRA SUNDELL PHONE NO : 408-845-4278 3200 LAKESIDE DRIVE SE DECISION MADE: 08-OCT-99 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95052-8167 DEVICE: RESPALERT HARWILL MEDICAL (PTY) LTD. 510(k) NO: K992618(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P O BOX 4341 SE DECISION MADE: 29-OCT-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: REP CHOLESTEROL PROFILE KIT HELENA LABORATORIES 510(k) NO: K992971(TRADITIONAL) ATTN: ERIC PETERSON PHONE NO : 800-231-5663 1530 LINDBERGH DR. SE DECISION MADE: 18-OCT-99 BEAUMONT, TX 77704 510(k) STATEMENT DEVICE: CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELE HENKE SASS WOLF OF AMERICA, INC. 510(k) NO: K991563(TRADITIONAL) ATTN: ELLEN HENKE PHONE NO : 781-934-9498 73 EAGLES NEST ROAD SE DECISION MADE: 13-OCT-99 DUXBURY, MA 02332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUMA COMFORT BOND + DESENSITIZER HERAEUS KULZER, INC. 510(k) NO: K992292(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662 4315 S.LAFAYETTE SE DECISION MADE: 01-OCT-99 SOUTH BEND, IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUMA COMFORT BOND HERAEUS KULZER, INC. 510(k) NO: K992985(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-291-0661 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 14-OCT-99 SOUTH BEND, IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3 HEWLETT-PACKARD CO. 510(k) NO: K993171(SPECIAL) ATTN: DAVE OSBORN PHONE NO : 978-659-3173 3000 MINUTEMAN ROAD SE DECISION MADE: 21-OCT-99 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A HEWLETT-PACKARD, HEALTHCARE SOLUTI510(k) NO: K992478(TRADITIONAL) ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114 2081 LONGDEN CIRCLE SE DECISION MADE: 15-OCT-99 LOS ALTOS, CA 94024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRIS, AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K992650(TRADITIONAL) ATTN: JAMES JOCHEN ROGERS PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 08-OCT-99 TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLICARE TRANSPARENT WOUND DRESSING HOLLISTER, INC. 510(k) NO: K991214(TRADITIONAL) ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849 2000 HOLLISTER DR. SE DECISION MADE: 14-OCT-99 LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, Q HOLOGIC, INC. 510(k) NO: K992775(TRADITIONAL) ATTN: NANDINI MURTHY PHONE NO : 781-999-7300 35 CROSBY DR. SE DECISION MADE: 01-OCT-99 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIVA HOVEROUND CORP. 510(k) NO: K991132(TRADITIONAL) ATTN: STAN COOPER PHONE NO : 800-964-6837 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 20-OCT-99 SARASOTA, FL 34243 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW HOWMEDICA OSTEONICS CORP. 510(k) NO: K993004(SPECIAL) ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283 359 VETERANS BLVD. SE DECISION MADE: 06-OCT-99 RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOWMEDICA OSTEONICS RESTORATION HA HIP STEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K993077(SPECIAL) ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117 59 ROUTE 17 SE DECISION MADE: 08-OCT-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS HOWMEDICA OSTEONICS CORP. 510(k) NO: K993181(SPECIAL) ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117 59 ROUTE 17 SE DECISION MADE: 22-OCT-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCISION ARTHROJET SYSTEM WITH CAUTERY HYDROCISION, INC. 510(k) NO: K993009(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 978-657-0020 220 BALLARDVALE STREET SE DECISION MADE: 25-OCT-99 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HTU3 HYOX SYSTEMS LTD. 510(k) NO: K984313(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH STREET, NW SE DECISION MADE: 22-OCT-99 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 HYSTERX, INC. 510(k) NO: K992714(TRADITIONAL) ATTN: JUDY F GORDON PHONE NO : 949-854-6314 18732 SAGINAW SE DECISION MADE: 05-OCT-99 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAOP CATHETER I-FLOW CORP. 510(k) NO: K991543(TRADITIONAL) ATTN: STANLEY E FRY PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 25-OCT-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERACOUSTICS EP 15 ABR STAND ALONE UNIT IDEM (INT'L DIST. OF ELECTRONICS F510(k) NO: K991853(TRADITIONAL) ATTN: DONNA WARD PHONE NO : 800-947-6334 4814 EAST SECOND ST. SE DECISION MADE: 25-OCT-99 BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K992796(TRADITIONAL) ATTN: MICHAEL RENNER PHONE NO : 407-757-2290 2290 EAU GALLIE BLVD. SE DECISION MADE: 25-OCT-99 MELBOURNE, FL 32935 510(k) STATEMENT DEVICE: ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST IMMCO DIAGNOSTICS, INC. 510(k) NO: K992878(TRADITIONAL) ATTN: KEVIN LAWSON PHONE NO : 716-691-0091 60 PINEVIEW DR. SE DECISION MADE: 15-OCT-99 BUFFALO, NY 14228 510(k) STATEMENT DEVICE: ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING IMPLANT INNOVATIONS, INC. 510(k) NO: K992334(TRADITIONAL) ATTN: WILLIAM G CONETY PHONE NO : 800-443-8166 4555 RIVERSIDE DR. SE DECISION MADE: 08-OCT-99 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2Y IMPLEX CORP. 510(k) NO: K992409(TRADITIONAL) ATTN: JOHN SCHLAGO PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 08-OCT-99 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSURE PRO TEST INBIOS INTL., INC. 510(k) NO: K992695(TRADITIONAL) ATTN: ESTELA RAYCHAUDHURI PHONE NO : 206-344-5821 562 1ST. AVE. SOUTH, SUITE 703 SE DECISION MADE: 18-OCT-99 SEATTLE, WA 98104 510(k) STATEMENT DEVICE: INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM INDIGO MEDICAL, INC. 510(k) NO: K992262(TRADITIONAL) ATTN: JACQUELYN A HUGHES PHONE NO : 513-786-7987 10123 ALLIANCE RD. SE DECISION MADE: 04-OCT-99 CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTITRAC INDIVIDUAL MONITORING SYSTEMS, INC510(k) NO: K992410(TRADITIONAL) ATTN: DAVID T KRAUSMAN PHONE NO : 410-296-7723 1055 TAYLOR AVE., SUITE 300 SE DECISION MADE: 15-OCT-99 BALTIMORE, MD 21286-8334 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 INFIMED, INC. 510(k) NO: K992575(TRADITIONAL) ATTN: RALPH J FLATAU PHONE NO : 315-453-4545 121 METROPOLITAN DR. SE DECISION MADE: 07-OCT-99 LIVERPOOL, NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RC TACK INNOVASIVE DEVICES, INC. 510(k) NO: K992377(TRADITIONAL) ATTN: KATHLEEN MORAHAN PHONE NO : 508-460-8229 734 FOREST ST. SE DECISION MADE: 08-OCT-99 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 INNOVASIVE DEVICES, INC. 510(k) NO: K992458(TRADITIONAL) ATTN: KATHLEEN MORAHAN PHONE NO : 580-460-8229 734 FOREST ST. SE DECISION MADE: 14-OCT-99 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAHO AUTOCLAVABLE CYSTOSCOPE INNOVATIVE ENDOSCOPY COMPONENTS, L510(k) NO: K992983(TRADITIONAL) ATTN: GERALD GOIGITZER PHONE NO : 954-217-8780 1112 WESTON RD., SUITE 227 SE DECISION MADE: 07-OCT-99 FT. LAUDERDALE, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2 INTERPORE CROSS INTL. 510(k) NO: K992369(TRADITIONAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 13-OCT-99 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO INTRASTENT INTRATHERAPEUTICS, INC. 510(k) NO: K992816(SPECIAL) ATTN: CATHY YOHNK PHONE NO : 612-697-2003 651 CAMPUS DR. SE DECISION MADE: 15-OCT-99 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM INVACARE CORP. 510(k) NO: K983627(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 P.O. BOX 4028 SE DECISION MADE: 22-OCT-99 ELYRIA, OH 44036-2125 510(k) STATEMENT DEVICE: MODEL IRC 1001 AEROSOL COMPRESSOR INVACARE CORP. 510(k) NO: K992643(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6000 ONE INVACARE WAY SE DECISION MADE: 27-OCT-99 ELYRIA, OH 44035-2125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMA-CATH FIXED CURVE EP CATHETERS IRVINE BIOMEDICAL, INC. 510(k) NO: K991025(SPECIAL) ATTN: ROGER TU PHONE NO : 949-851-3053 2146-A MICHELSON DR. SE DECISION MADE: 15-OCT-99 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIO 300 ITO CO., LTD. 510(k) NO: K990787(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 2300 TWINBROOK PARKWAY, SE DECISION MADE: 20-OCT-99 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: ATD AUTOMATIC BRIDGE REMOVER J. MORITA USA, INC. 510(k) NO: K992649(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 601 13TH STREET, N.W. SE DECISION MADE: 29-OCT-99 SUITE 500 NORTH 510(k) STATEMENT WASHINGTON, DC 20005 DEVICE: JEL BIOS 10 (CODE NAME RD-1801) J.F. JELENKO & CO., INC. 510(k) NO: K993136(TRADITIONAL) ATTN: TRIDIB R DASGUPTA PHONE NO : 914-273-8600 99 BUSINESS PARK DR. SE DECISION MADE: 21-OCT-99 ARMONK, NY 10504 510(k) STATEMENT DEVICE: JEL BIOS 18 (CODE NAME RD- 1214) J.F. JELENKO & CO., INC. 510(k) NO: K993152(TRADITIONAL) ATTN: TRIDIB DASGUPTA PHONE NO : 914-273-8600 99 BUSINESS PARK DR. SE DECISION MADE: 21-OCT-99 ARMONK, NY 10504 510(k) STATEMENT DEVICE: GOLD CORE 55 JENERIC/PENTRON, INC. 510(k) NO: K993173(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 26-OCT-99 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLD CORE 75 JENERIC/PENTRON, INC. 510(k) NO: K993175(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 26-OCT-99 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG JORDCO, INC. 510(k) NO: K992484(TRADITIONAL) ATTN: HAL J OIEN PHONE NO : 503-531-3904 595 N.W. 167TH AVE. SE DECISION MADE: 14-OCT-99 BEAVERTON, OR 97006 510(k) STATEMENT DEVICE: IRRIGATION OR INFUSION PUMP "K" PUMP K.M.I. KOLSTER METHODS INC. 510(k) NO: K991203(TRADITIONAL) ATTN: ALWIN H KOLSTER PHONE NO : 714-956-1964 2550 WEST ROWLAND AVE. SE DECISION MADE: 15-OCT-99 ANAHEIM, CA 92804 510(k) STATEMENT DEVICE: K-ASSAY APO AI KAMIYA BIOMEDICAL CO. 510(k) NO: K993345(TRADITIONAL) ATTN: COLIN GETTY PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 25-OCT-99 SEATTLE, WA 98188-3412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-ASSAY APO B KAMIYA BIOMEDICAL CO. 510(k) NO: K993354(TRADITIONAL) ATTN: COLIN GETTY PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 28-OCT-99 SEATTLE, WA 98188-3412 510(k) STATEMENT DEVICE: KSEA SCBCOM KARL STORZ ENDOSCOPY 510(k) NO: K992469(TRADITIONAL) ATTN: KEVIN A KENNAN PHONE NO : 800-421-0837 600 CORPORATE POINTE SE DECISION MADE: 15-OCT-99 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KONICA LASER IMAGER, DRYPRO MODEL 722 KONICA CORP. 510(k) NO: K992586(TRADITIONAL) ATTN: KAY HAMAGUCHI PHONE NO : 81 596 373609 319 AKENO, OBATA-CHO SE DECISION MADE: 29-OCT-99 WATARAI-GUN 510(k) STATEMENT MIE-KEN, JAPAN 5190501 DEVICE: SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES LEONHARD LANG CO. 510(k) NO: K982521(TRADITIONAL) ATTN: BURRHUS LANG PHONE NO : 435 123 34257 ARCHENWEG 65 SE DECISION MADE: 26-OCT-99 INNSBRUCK, AUSTRIA A-6020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTORBLADE SUTURE ANCHOR LI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K993373(SPECIAL) ATTN: RHODEMANN LI PHONE NO : 203-944-2800 4 ARMSTRONG RD. SE DECISION MADE: 27-OCT-99 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, M LIGHT DIAGNOSTICS 510(k) NO: K990141(TRADITIONAL) ATTN: CINDY PENNY PHONE NO : 909-676-8080 28835 SINGLE OAK DR. SE DECISION MADE: 19-OCT-99 TEMECULA, CA 92590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DR. JAHANGER'S CUTTER M.S. JAHANGER, MD 510(k) NO: K990738(TRADITIONAL) ATTN: MOHAMMED JAHANGER PHONE NO : 609-582-0033 440 EGG HARBOR ROAD SE DECISION MADE: 29-OCT-99 TUENERSVILLE, NJ 08012 510(k) STATEMENT DEVICE: SUPER SOOTHER MART TILLER CORP. 510(k) NO: K991914(TRADITIONAL) ATTN: JIMMY DONG PHONE NO : 886 225 929119 4TH FL. NO.2 MING TSU E. RD. SE DECISION MADE: 06-OCT-99 TAIPEI, CHINA (TAIWAN) 104 510(k) STATEMENT DEVICE: MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, MASIMO CORP. 510(k) NO: K992238(TRADITIONAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 08-OCT-99 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -AD MASIMO CORP. 510(k) NO: K992340(TRADITIONAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 08-OCT-99 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE MAXXIM MEDICAL 510(k) NO: K992865(TRADITIONAL) ATTN: JOYCE MOODY PHONE NO : 813-814-4817 477 COMMERCE BLVD SE DECISION MADE: 13-OCT-99 OLDSMAR, FL 34677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PIN MEDTEXX PARTNERS, INC. 510(k) NO: K993080(TRADITIONAL) ATTN: E. J SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 20-OCT-99 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC AVE BRIDGE STENT MEDTRONIC AVE, INC. 510(k) NO: K993145(SPECIAL) ATTN: SUSAN WALTON PHONE NO : 707-591-7315 2330A CIRCADIAN WAY SE DECISION MADE: 21-OCT-99 SANTA ROSA, CA 95407-5415 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETCO2 VITAL SIGNS MODULE MENNEN MEDICAL, INC. 510(k) NO: K983864(TRADITIONAL) ATTN: KENNETH RAICHMAN PHONE NO : 972 893 83030 KIRYAT WEIZMANN SE DECISION MADE: 08-OCT-99 REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MBA MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K993057(SPECIAL) ATTN: CHESTER MCCOY PHONE NO : 801-253-1600 1600 WEST MERIT PKWY. SE DECISION MADE: 05-OCT-99 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLISYSTEM II COLOR MONITOR MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K993341(SPECIAL) ATTN: CHESTER MCCOY PHONE NO : 801-253-1600 1600 WEST MERIT PKWY. SE DECISION MADE: 25-OCT-99 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPRING-WOUND EPIDURAL CATHETER MICOR INC. 510(k) NO: K991879(TRADITIONAL) ATTN: CHARLES W ESLEEP PHONE NO : 412-487-1113 2855 OXFORD BLVD. SE DECISION MADE: 28-OCT-99 ALLISON PARK, PA 15101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: .010" SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014" SILVERSPED HYDR MICRO THERAPEUTICS, INC. 510(k) NO: K993257(SPECIAL) ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 21-OCT-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 MICRON CORP. 510(k) NO: K991239(TRADITIONAL) ATTN: EIJI SUZUKI PHONE NO : 813 372 60396 SE DECISION MADE: 18-OCT-99 510(k) STATEMENT DEVICE: MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 MICROWAVE MEDICAL, INC. 510(k) NO: K991456(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 25-OCT-99 IRVINE, CA 92606 510(k) STATEMENT DEVICE: VIRGO MRI SYSTEM MILLENNIUM TECHNOLOGY SERVICES 510(k) NO: K990153(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LN., #C-100 SE DECISION MADE: 08-OCT-99 PLEASANT HILL, CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OBC-085 BREAST ARRAY COIL MRI DEVICES CORP. 510(k) NO: K993233(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402 N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 15-OCT-99 JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT WAUKESHA, WI 53186 DEVICE: QWH-085 WRIST ARRAY COIL MRI DEVICES CORP. 510(k) NO: K993235(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402 N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 15-OCT-99 JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT WAUKESHA, WI 53186 DEVICE: QSC-085 SHOULDER ARRAY COIL MRI DEVICES CORP. 510(k) NO: K993279(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 414-525-1402 N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 15-OCT-99 JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT WAUKESHA, WI 53186 DEVICE: IV ADMINISTRATION SET NEW ALLIANCE OF INDEPENDENT MEDICA510(k) NO: K992266(TRADITIONAL) ATTN: EDWARD THIBON PHONE NO : 626-445-3090 99 W. SANDRA AVE. SE DECISION MADE: 27-OCT-99 ARCADIA, CA 91007 510(k) STATEMENT DEVICE: NEUROFAX, MODEL EEG-1100A NIHON KOHDEN, INC. 510(k) NO: K992742(TRADITIONAL) ATTN: BONNIE BISHOP PHONE NO : 949-250-3959 2601 CAMPUS DR. SE DECISION MADE: 14-OCT-99 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREFERENCE TREATMENT SYSTEM NORTHWEST MEDICAL PHYSICS EQUIPMEN510(k) NO: K983793(TRADITIONAL) ATTN: LEE MYERS PHONE NO : 425-672-2841 21031 67TH AVE. WEST SE DECISION MADE: 05-OCT-99 LYNNWOOD, WA 98036 510(k) STATEMENT DEVICE: CET PROSTATE APPLICATOR SET, PART NUMBER 089.066 NUCLETRON CORP. 510(k) NO: K990990(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DRIVE SE DECISION MADE: 07-OCT-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM NUVASIVE, INC. 510(k) NO: K990324(TRADITIONAL) ATTN: STEVE REITZLER PHONE NO : 619-977-1465 13221 MARICOTTE PLACE SE DECISION MADE: 05-OCT-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES NUVASIVE, INC. 510(k) NO: K992782(TRADITIONAL) ATTN: STEVE REITZLER PHONE NO : 858-271-7070 10065 OLD GROVE ROAD, SUITE A SE DECISION MADE: 05-OCT-99 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K992466(TRADITIONAL) ATTN: CHARLES R VERMETTE PHONE NO : 510-724-0384 629 TENNENT AVE. SE DECISION MADE: 04-OCT-99 PINOLE, CA 94564 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASS (MICRO-ACCESS SPINE SYSTEM) OMNI-TRACT SURGICAL, DIV. MINN. SC510(k) NO: K992583(TRADITIONAL) ATTN: MICHAEL PONTIUS PHONE NO : 612-623-0396 1100 NEW BRIGHTON BLVD. SE DECISION MADE: 29-OCT-99 MINNEAPOLIS, MN 55413-1660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPAP OPAP, INC. 510(k) NO: K991926(TRADITIONAL) ATTN: WILLIAM T HART PHONE NO : 209-295-5562 26037 SUGAR PINE DR. SE DECISION MADE: 18-OCT-99 PIONEER, CA 95666-0189 510(k) STATEMENT DEVICE: ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTE ORATEC INTERVENTIONS, INC. 510(k) NO: K991140(TRADITIONAL) ATTN: SHEILA RAMERMAN PHONE NO : 650-687-3475 3700 HAVEN CT. SE DECISION MADE: 25-OCT-99 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103 ORIENTAL SYSTEM TECHNOLOGY INC. 510(k) NO: K992601(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD SE DECISION MADE: 27-OCT-99 SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: CONTOUR SPINAL SYSTEM ORTHO DEVELOPMENT CORP. 510(k) NO: K990986(TRADITIONAL) ATTN: CAROL FREASIER PHONE NO : 801-553-9993 106 WEST 12200 SOUTH SE DECISION MADE: 14-OCT-99 DRAPER, UT 84020 510(k) STATEMENT DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMM ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K993068(SPECIAL) ATTN: MARLENE SHULMAN PHONE NO : 716-453-4041 100 INDIGO CREEK DRIVE SE DECISION MADE: 04-OCT-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K992366(TRADITIONAL) ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041 100 INDIGO CREEK DR. SE DECISION MADE: 08-OCT-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACIFIC IMPLANT TITANIUM ENDODONTIC POINT PACIFIC IMPLANT, INC. 510(k) NO: K992582(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000 2000 M. STREET N.W. 7TH FLOOR SE DECISION MADE: 21-OCT-99 WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATI PAMITEX INDUSTRIES SDN BHD 510(k) NO: K991474(TRADITIONAL) ATTN: AZMAN ISMAIL PHONE NO : 011 606 6313122 BATU 2 1/2, JALAN RASAH SE DECISION MADE: 06-OCT-99 SEREMBAN, N.S., MALAYSIA 70300 510(k) STATEMENT DEVICE: HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMIN PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992523(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 18-OCT-99 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) PAMITEX INDUSTRIES SDN BHD 510(k) NO: K993093(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 29-OCT-99 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GL PAMITEX INDUSTRIES SDN BHD 510(k) NO: K993097(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 27-OCT-99 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTE PAN-CENTURY RUBBER PRODUCTS SDN. B510(k) NO: K993287(TRADITIONAL) ATTN: H.R.K. MURTHY PHONE NO : 60 07 2518551 LOT 230, JALAN TIMAH 2, SE DECISION MADE: 29-OCT-99 PASIR GUDANG INDUSTRIAL ESTATE 510(k) STATEMENT PASIR GUDANG, JOHOR, MALAYSIA 81700 DEVICE: PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN PASCO LABORATORIES, INC. 510(k) NO: K992507(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 800-321-9813 12750 WEST 42ND AVE. SE DECISION MADE: 08-OCT-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS, MEROPENEM PASCO LABORATORIES, INC. 510(k) NO: K992546(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 12-OCT-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE PASCO LABORATORIES, INC. 510(k) NO: K992562(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 13-OCT-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS, CEFOTAXIME PASCO LABORATORIES, INC. 510(k) NO: K992568(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 14-OCT-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL PASCO LABORATORIES, INC. 510(k) NO: K992593(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 800-321-9813 12750 WEST 42ND AVE. SE DECISION MADE: 14-OCT-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS, PENICILLIN PASCO LABORATORIES, INC. 510(k) NO: K992646(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 19-OCT-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN PASCO LABORATORIES, INC. 510(k) NO: K992647(TRADITIONAL) ATTN: LINDO K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 19-OCT-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMOBIL POWERED WHEELCHAIR 1280 PERMOBIL A.B. 510(k) NO: K991658(ABBREVIATED) ATTN: BENGT PERSSON PHONE NO : 468 929 150 ENGELBREKTS VAG 101 SE DECISION MADE: 08-OCT-99 SOLLENTUNA, SWEDEN S-191 62 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C PHAMATECH 510(k) NO: K992685(SPECIAL) ATTN: CARL A MONGIOVI PHONE NO : 619-635-5840 9265 ACTIVITY RD., #112-113 SE DECISION MADE: 06-OCT-99 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 PHAMATECH 510(k) NO: K993165(SPECIAL) ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840 9265 ACTIVITY RD., #112-113 SE DECISION MADE: 20-OCT-99 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS GYROSCAN INTERA (*) PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K992533(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7031 710 BRIDGEPORT AVE. SE DECISION MADE: 18-OCT-99 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEWPOINT ENT/ORTHOPEDIC OPTION PICKER INTERNATIONAL, INC. 510(k) NO: K991256(TRADITIONAL) ATTN: ELAINE K KEELER PHONE NO : 440-473-5591 595 MINER RD. SE DECISION MADE: 08-OCT-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEACON-P, MODEL 211059 PICKER INTERNATIONAL, INC. 510(k) NO: K992335(TRADITIONAL) ATTN: RONALD J MARTONE PHONE NO : 440-473-7651 595 MINER RD. SE DECISION MADE: 07-OCT-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCAREASE SHEETS & SCAREASE GEL PILLAR SURGICAL 510(k) NO: K991970(TRADITIONAL) ATTN: ROB FRITZENKOTTER PHONE NO : 619-295-6511 PO BOX 8141 SE DECISION MADE: 25-OCT-99 LA JOLLA, CA 92038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIPPY PILLAR TECHNOLOGY, INC. 510(k) NO: K983808(TRADITIONAL) ATTN: CHRIS TINSLEY PHONE NO : 316-325-2629 1101 ILLINOIS SE DECISION MADE: 14-OCT-99 NEODESHA, KS 66757 510(k) STATEMENT DEVICE: SDB CERCLAGE SYSTEM PIONEER LABORATORIES, INC. 510(k) NO: K992616(TRADITIONAL) ATTN: BURNS SEVERSON PHONE NO : 906-226-9909 375 RIVER PARK CIRCLE SE DECISION MADE: 27-OCT-99 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEX BUTTON PIONEER LABORATORIES, INC. 510(k) NO: K992617(TRADITIONAL) ATTN: BURNS SEVERSON PHONE NO : 906-226-9909 375 RIVER PARK CIRCLE SE DECISION MADE: 27-OCT-99 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRICOTHYROTOMY TUBE POLAMEDCO, INC. 510(k) NO: K983000(TRADITIONAL) ATTN: JERRY W HARRER PHONE NO : 310-577-1422 4054 GLENCOE AVE. SE DECISION MADE: 27-OCT-99 MARINA DEL REY, CA 90292-5608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER POROUS MEDIA CORP. 510(k) NO: K990276(TRADITIONAL) ATTN: ROCHELLE M MICKSCHL PHONE NO : 651-653-2000 1350 HAMMOND RD. SE DECISION MADE: 01-OCT-99 ST. PAUL, MN 55110 510(k) STATEMENT DEVICE: PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES PURILENS, INC. 510(k) NO: K991965(TRADITIONAL) ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY SE DECISION MADE: 01-OCT-99 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI PURITAN BENNETT CORP. 510(k) NO: K993088(SPECIAL) ATTN: TONY KEAVENEY PHONE NO : 314-498-3365 2200 FARADAY AVENUE SE DECISION MADE: 08-OCT-99 ST. CHARLES, MO 63304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM PURITAN BENNETT CORP. 510(k) NO: K993220(SPECIAL) ATTN: TONY KEAVENEY PHONE NO : 314-498-3365 3 MISSOURI RESEARCH PARK DR. SE DECISION MADE: 22-OCT-99 ST.CHARLES, MO 63304-5685 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERAQUEST EB VCA IGG QUEST INTL., INC. 510(k) NO: K990410(TRADITIONAL) ATTN: ROBERT A CORT PHONE NO : 305-948-8788 1938 N.E. 148TH TERR. SE DECISION MADE: 28-OCT-99 NORTH MIAMI, FL 33181 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERAQUEST EB VAC IGM QUEST INTL., INC. 510(k) NO: K990977(TRADITIONAL) ATTN: ROBERT A CORT PHONE NO : 305-948-8788 1938 N.E. 148TH TERR. SE DECISION MADE: 06-OCT-99 NORTH MIAMI, FL 33181 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDI-SCREEN REDWOOD BIOTECH INC. 510(k) NO: K993100(SPECIAL) ATTN: JANIS FREESTONE PHONE NO : 650-691-4770 2440 LEGHORN ST. SE DECISION MADE: 06-OCT-99 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARIA LX CPAP SYSTEM RESPIRONICS, INC. 510(k) NO: K993307(SPECIAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE DR. SE DECISION MADE: 27-OCT-99 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUOSO LX SMART CPAP SYSTEM RESPIRONICS, INC. 510(k) NO: K993433(SPECIAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE DR. SE DECISION MADE: 27-OCT-99 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) RI MOS. S.R.L. 510(k) NO: K992926(TRADITIONAL) ATTN: ADENA S RIEMER PHONE NO : 978-371-0066 100 MAIN STREET SE DECISION MADE: 26-OCT-99 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA CONCORD, MA 01742 DEVICE: FLEXIBLE FIBERSCOPES & ACCESSORIES RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K990397(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 25-OCT-99 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SAFESKIN CORP. 510(k) NO: K992830(TRADITIONAL) ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010 12671 HIGH BLUFF DR. SE DECISION MADE: 27-OCT-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAYPAX WEB CLINICAL SYSTEM SAMSUNG SDS CO., LTD 510(k) NO: K992426(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 513-786-7458 2001 EAST OAKSHORES DRIVE SE DECISION MADE: 13-OCT-99 CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECT-SUTTER MICRO BIPOLAR FORCEPS SELECT MEDIZINTECHNIK HERMANN SUTT510(k) NO: K992760(TRADITIONAL) ATTN: ANITA THIBEAULT PHONE NO : 678-461-5559 9070 BLUFFVIEW TRACE SE DECISION MADE: 25-OCT-99 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES SHANGHAI COSMOS CORP. 510(k) NO: K992271(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 410 SE DECISION MADE: 01-OCT-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANGHAI COSMOS CORP. 510(k) NO: K992272(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 410 SE DECISION MADE: 01-OCT-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K992555(TRADITIONAL) ATTN: KAREN ABEL PHONE NO : 909-590-9358 13945 MAGNOLIA AVE SE DECISION MADE: 14-OCT-99 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K992861(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 13945 MAGNOLIA AVE SE DECISION MADE: 06-OCT-99 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVE SHIJIAZHUANG HONGRAY PLASTIC PRODU510(k) NO: K992922(TRADITIONAL) ATTN: GUI-XI LIU PHONE NO : 011 863 113613127 NO. 135 XIN-HUA WEST RD. SE DECISION MADE: 06-OCT-99 SHIJIAZHUANG, CHINA 050081 510(k) STATEMENT DEVICE: SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES SHINEMOUND ENTERPRISE, INC. 510(k) NO: K993231(TRADITIONAL) ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980 17A STERLING RD. SE DECISION MADE: 27-OCT-99 NORTH BILLERICA, MA 01862 510(k) STATEMENT DEVICE: SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLO SHINEMOUND ENTERPRISE, INC. 510(k) NO: K993240(TRADITIONAL) ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980 17A STERLING RD. SE DECISION MADE: 27-OCT-99 NORTH BILLERICA, MA 01862 510(k) STATEMENT DEVICE: P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM SIMS DELTEC, INC. 510(k) NO: K992880(TRADITIONAL) ATTN: LISA J STONE PHONE NO : 651-633-2556 1265 GREY FOX RD. SE DECISION MADE: 19-OCT-99 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# SIMS PORTEX, INC. 510(k) NO: K992471(TRADITIONAL) ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 22-OCT-99 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST-302 INFRAREX SKYLARK DEVICE CO., LTD. 510(k) NO: K990233(TRADITIONAL) ATTN: GEORGE K. C CHEN PHONE NO : 886 225 979005 12FL, 34, SEC. 3 SE DECISION MADE: 27-OCT-99 CHUNG SHAN N. ROAD 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: IQ NASAL MASK, MODEL P/N 50160 SLEEPNET CORP. 510(k) NO: K993269(SPECIAL) ATTN: PAUL R CHIESA PHONE NO : 603-624-1911 1050 PERIMETER RD., SE DECISION MADE: 27-OCT-99 LOCKHEED AIR CENTER 510(k) STATEMENT MANCHESTER, NH 03103 DEVICE: DYONICS VARICOSE VEIN ABLATION BLADE SMITH & NEPHEW, INC. 510(k) NO: K990723(TRADITIONAL) ATTN: DEBORAH CONNORS PHONE NO : 978-749-1000 160 DASCOMB RD. SE DECISION MADE: 05-OCT-99 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS SMITH & NEPHEW, INC. 510(k) NO: K991026(ABBREVIATED) ATTN: EHAB M ESMAIL PHONE NO : 901-396-2121 1450 BROOKS RD. SE DECISION MADE: 22-OCT-99 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTIL-A ORAL PROTECTOR SOMATICS, INC. 510(k) NO: K992269(TRADITIONAL) ATTN: RICHARD ABRAMS PHONE NO : 847-234-6761 910 SHERWOOD DR., UNIT 17 SE DECISION MADE: 25-OCT-99 LAKE BLUFF, IL 60044 510(k) STATEMENT DEVICE: SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 SORING GMBH MEDIZINTECHNIK 510(k) NO: K993265(SPECIAL) ATTN: CARL ALLETTO PHONE NO : 513-786-7458 3200 DOGWOOD COURT SE DECISION MADE: 22-OCT-99 CINCINNATI, OH 45140 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 125 IMPLANT SEEDS, MODEL STM1251 SOURCETECH MEDICAL, L.L.C. 510(k) NO: K991280(TRADITIONAL) ATTN: DAVID T SIERACKI PHONE NO : 630-933-7610 295 E. LIES RD. SE DECISION MADE: 20-OCT-99 CAROL STREAM, IL 60188 510(k) STATEMENT DEVICE: CARDIOQUANT TROPONIN I TEST SPECTRAL DIAGNOSTICS INC. 510(k) NO: K992127(TRADITIONAL) ATTN: FRANCEE S BOCHES PHONE NO : 305-593-1991 5550 N.W. 102 PLACE SE DECISION MADE: 04-OCT-99 MIAMI, FL 33178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER SPECTRANETICS CORP. 510(k) NO: K990713(TRADITIONAL) ATTN: MICHAEL J QUINN PHONE NO : 719-633-8333 96 TALAMINE CT. SE DECISION MADE: 22-OCT-99 COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRUM DESIGNS SPECTRAGEL SPECTRUM DESIGNS, INC. 510(k) NO: K992522(TRADITIONAL) ATTN: JIM DISHMAN PHONE NO : 800-239-6399 6387 B ROSE LANE SE DECISION MADE: 26-OCT-99 CARPINETERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY STARION INSTRUMENTS 510(k) NO: K992460(TRADITIONAL) ATTN: GEORGE HERMANN PHONE NO : 408-741-8773 22900 CONGRESS SPRINGS ROAD SE DECISION MADE: 05-OCT-99 SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STENTOR, PAGEVIEW STENTOR, INC 510(k) NO: K992698(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 25-OCT-99 SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARIATRIC LAPAROSCOPE, MODEL 367 STRYKER ENDOSCOPY 510(k) NO: K993045(TRADITIONAL) ATTN: ROBERT H DAHLA PHONE NO : 408-567-2401 2590 WALSH AVE. SE DECISION MADE: 27-OCT-99 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM STRYKER INSTRUMENTS 510(k) NO: K991696(TRADITIONAL) ATTN: NICOLE PETTY PHONE NO : 616-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 25-OCT-99 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER T STRYKER INSTRUMENTS 510(k) NO: K993148(SPECIAL) ATTN: SUZANNE VELAZQUEZ PHONE NO : 616-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 15-OCT-99 KALAMAZOO, MI 49001 510(k) STATEMENT DEVICE: ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 SULZER CARBOMEDICS, INC. 510(k) NO: K992056(TRADITIONAL) ATTN: ROBERT M WOLFARTH PHONE NO : 512-435-3467 1300 EAST ANDERSON LN. SE DECISION MADE: 12-OCT-99 AUSTIN, TX 78752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM SULZER SPINE-TECH 510(k) NO: K992276(TRADITIONAL) ATTN: JANELL A COLLEY PHONE NO : 612-832-6205 7375 BUSH LAKE RD. SE DECISION MADE: 01-OCT-99 MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES SUPERMAX SDN BHD 510(k) NO: K993258(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 657 2328 LOT 42, JALAN BRP 9/2, BUKIT SE DECISION MADE: 27-OCT-99 RAHMAN PUTRA,PUTRA INDUSTRIAL 510(k) STATEMENT 47000 SUNGAI BULOH-SELANGOR, MALAYSIA DEVICE: SNT IMAGE ANALYSIS SYSTEM SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K992354(TRADITIONAL) ATTN: ROGER N WHITE PHONE NO : 303-439-9709 530 COMPTON ST. SE DECISION MADE: 12-OCT-99 BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTEC-E IRRIGATION SYSTEM 2 SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K992195(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 08-OCT-99 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD SYNTHES (USA) 510(k) NO: K990637(TRADITIONAL) ATTN: ANGELA SILVESTRI PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 22-OCT-99 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM SYNTHES (USA) 510(k) NO: K992837(TRADITIONAL) ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700 1600 RUSSELL RD. SE DECISION MADE: 25-OCT-99 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKSTRIP ONE STEP OPIATES TEST SYNTRON BIORESEARCH, INC. 510(k) NO: K993490(TRADITIONAL) ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223 1420 LOS ANGELES AVE. SE DECISION MADE: 29-OCT-99 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA SIMI VALLEY, CA 93065 DEVICE: QUICKPAC II ONE STEP OPIATES TEST SYNTRON BIORESEARCH, INC. 510(k) NO: K993491(TRADITIONAL) ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223 1420 LOS ANGELES AVE. SE DECISION MADE: 29-OCT-99 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA SIMI VALLEY, CA 93065 DEVICE: MINI-PORT TAUT, INC. 510(k) NO: K992904(TRADITIONAL) ATTN: RONALD KENSETH PHONE NO : 630-232-2507 2571 KANEVILLE COURT SE DECISION MADE: 05-OCT-99 GENEVA, IL 60134 510(k) STATEMENT DEVICE: INTRADUCER TAUT, INC. 510(k) NO: K992907(TRADITIONAL) ATTN: RONALD KENSETH PHONE NO : 630-232-2507 2571 KANEVILLE COURT SE DECISION MADE: 05-OCT-99 GENEVA, IL 60134 510(k) STATEMENT DEVICE: TECHNOSANAT KRYO TSK 2005 TECHNOSANAT INNOVATIVE MEDIZINTECH510(k) NO: K992536(TRADITIONAL) ATTN: WILLIAM KELLEY PHONE NO : 949-660-2950 2525 MCGAW AVE SE DECISION MADE: 08-OCT-99 IRVINE, CA 92623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500 TEFTEC CORP. 510(k) NO: K992627(TRADITIONAL) ATTN: THOMAS E FINCH PHONE NO : 830-885-7588 6929 OLD SPRING BRANCH RD. SE DECISION MADE: 25-OCT-99 SPRING BRANCH, TX 78070-5104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400 TEFTEC CORP. 510(k) NO: K992628(TRADITIONAL) ATTN: THOMAS E FINCH PHONE NO : 830-885-7588 6929 OLD SPRING BRANCH RD. SE DECISION MADE: 25-OCT-99 SPRING BRANCH, TX 78070-5104 510(k) STATEMENT DEVICE: TES-20 TES ELECTRICAL ELECTRONIC CORP. 510(k) NO: K992425(TRADITIONAL) ATTN: MIKE Z CHEN PHONE NO : 886 223 939142 NO.57 JEN-AI ROAD SEC. 2 SE DECISION MADE: 19-OCT-99 TAIPEI, TAIWAN 300, CHINA 300 510(k) STATEMENT DEVICE: TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES TG MEDICAL SDN BHD 510(k) NO: K992360(TRADITIONAL) ATTN: WEE-CHAI LIM PHONE NO : 603 392 7880 LOT 5091, JALAN TERATAI, BT 5, SE DECISION MADE: 12-OCT-99 OFF JLN MERU 510(k) STATEMENT KLANG, SELANGOR D.E., MALAYSIA 41050 DEVICE: TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES TG MEDICAL SDN BHD 510(k) NO: K992841(TRADITIONAL) ATTN: WEE-CHAI LIM PHONE NO : 603 392 7880 LOT 5091, JALAN TERATAI, BT 5, SE DECISION MADE: 29-OCT-99 OFF JLN MERU 510(k) STATEMENT KLANG, SELANGOR D.E., MALAYSIA 41050 DEVICE: THE LEADAWAY THERAPY EQUIPMENT INC. 510(k) NO: K992372(TRADITIONAL) ATTN: GLENN BUCHAN PHONE NO : 800-940-6962 13860 WELLINGTON TRACE, #310 SE DECISION MADE: 13-OCT-99 WEST PALM BEACH, FL 33414 510(k) STATEMENT DEVICE: TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K993038(TRADITIONAL) ATTN: DIANA THORSON PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 07-OCT-99 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92681-2068 DEVICE: ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM TRANSFUSION TECHNOLOGIES CORP. 510(k) NO: K992723(TRADITIONAL) ATTN: JOHN J SOKOLOWSKI PHONE NO : 508-655-2277 9 ERIE DR. SE DECISION MADE: 18-OCT-99 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM TRIMEDYNE, INC. 510(k) NO: K992574(TRADITIONAL) ATTN: SUSAN H GAMBLE PHONE NO : 949-559-5300 2801 BARRANCA RD. SE DECISION MADE: 29-OCT-99 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE U.S. BIOMATERIALS CORP. 510(k) NO: K992416(TRADITIONAL) ATTN: ALBERT FOSMOE PHONE NO : 904-462-7660 ONE PROGRESS BLVD. SE DECISION MADE: 15-OCT-99 ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOREZ ULTRADENT PRODUCTS, INC. 510(k) NO: K992097(TRADITIONAL) ATTN: SCOTT E MOORE PHONE NO : 801-572-4200 505 WEST 10200 SOUTH SE DECISION MADE: 26-OCT-99 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: ENDO-EZE MOTOR AND HANDPIECE ULTRADENT PRODUCTS, INC. 510(k) NO: K992380(TRADITIONAL) ATTN: SCOTT E MOORE PHONE NO : 801-572-4200 505 WEST 10200 SOUTH SE DECISION MADE: 13-OCT-99 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: NEXT GENERATION RODDING SYSTEM UNITED STATES SURGICAL CORP. 510(k) NO: K992784(TRADITIONAL) ATTN: LUIS NESPRIDO PHONE NO : 203-845-1552 150 GLOVER AVE. SE DECISION MADE: 27-OCT-99 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEXIDE BIPOLAR FORCEPS II** DEVICE UNITED STATES SURGICAL CORP. 510(k) NO: K993055(TRADITIONAL) ATTN: CHRISTOPHER A GRAHAM PHONE NO : 203-845-1390 150 GLOVER AVE. SE DECISION MADE: 05-OCT-99 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.T.S., INC. (V.T.-3) V.T.S.,INC. 510(k) NO: K992442(TRADITIONAL) ATTN: DENNIS BELL PHONE NO : 701 S. MAIN SE DECISION MADE: 05-OCT-99 NEWKIRK, OK 74647 510(k) STATEMENT DEVICE: NUTRISAFE EXTENSION TUBE VYGON CORP. 510(k) NO: K991918(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVE. SE DECISION MADE: 29-OCT-99 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: SURGEON "POWDER-FREE" GLOVES, LATEX, STERILE WEAR SAFE MALAYSIA SDN. BHD. 510(k) NO: K992679(TRADITIONAL) ATTN: CLAUDE COTTET PHONE NO : 03 376 3525 LOT 1, LEBOH HISHAMUDDIN SATU, SE DECISION MADE: 21-OCT-99 NORTH KLANG STRAITS IND. AREA 510(k) STATEMENT PORT KLANG, SELANGOR, D.E., MALAYSIA 42000 DEVICE: MAPS 10000 WEB LINK MEDICAL 510(k) NO: K992560(TRADITIONAL) ATTN: MELISSA MAHALL PHONE NO : 301-623-2500 11800 BALTIMORE AVE SE DECISION MADE: 29-OCT-99 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BELTSVILLE, MD 20850 DEVICE: DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERIL WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K990750(TRADITIONAL) ATTN: CHENG HEAN KHOO PHONE NO : 603 846 2055 LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 15-OCT-99 BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900 DEVICE: DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K990752(TRADITIONAL) ATTN: CHENG HEAN KHOO PHONE NO : 603 846 2055 LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 18-OCT-99 BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900 DEVICE: XRT 600 R/F, WRF 0600 WUESTEC MEDICAL, INC. 510(k) NO: K992603(TRADITIONAL) ATTN: BRENDA S DAVIS PHONE NO : 334-408-0200 5600 COMMERCE BLVD., EAST SE DECISION MADE: 25-OCT-99 MOBILE, AL 36619-0037 510(k) STATEMENT DEVICE: ACCUGUIDE MUSCLE INJECTION MONITOR XOMED SURGICAL PRODUCTS, INC. 510(k) NO: K990793(TRADITIONAL) ATTN: DAVID TIMLIN PHONE NO : 904-279-7532 6743 SOUTHPOINT DR. N. SE DECISION MADE: 22-OCT-99 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE XOMED, INC. 510(k) NO: K992869(TRADITIONAL) ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 07-OCT-99 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZMR HIP SYSTEM-REVISION TAPER ZIMMER, INC. 510(k) NO: K992667(TRADITIONAL) ATTN: KAREN CAIN PHONE NO : 219-372-4219 345 E. MAIN ST. SE DECISION MADE: 27-OCT-99 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL M SERIES 12SL ANALYSIS OPTION ZOLL MEDICAL CORP. 510(k) NO: K991556(TRADITIONAL) ATTN: PAUL DIAS PHONE NO : 800-242-9150 32 SECOND AVENUE SE DECISION MADE: 21-OCT-99 BURLINGTON, MA 01803-4420 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 279 TOTAL WITH SUMMARIES 202 TOTAL WITH STATEMENTS 77
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