-
Medical Devices
-
May 1999 510(k) Clearances
DEVICE: ALBUMIN BCG, MODEL AL 103-01 A.P. TOTAL CARE, INC. 510(k) NO: K990978(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: BUN, MODEL BU 104-01 A.P. TOTAL CARE, INC. 510(k) NO: K990980(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R A.P. TOTAL CARE, INC. 510(k) NO: K990981(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 A.P. TOTAL CARE, INC. 510(k) NO: K991108(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRO A.P. TOTAL CARE, INC. 510(k) NO: K991109(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), P A.P. TOTAL CARE, INC. 510(k) NO: K991111(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: TOTAL IRON, MODELS FE 109-01, FE 109-02 A.P. TOTAL CARE, INC. 510(k) NO: K991244(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: URIC ACID, MODEL UA112-01 A.P. TOTAL CARE, INC. 510(k) NO: K991247(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT 06606 DEVICE: WALKCARE P200 SYSTEM A.STEIN-REGULATORY AFFAIRS CONSULT510(k) NO: K973592(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 979 20673 P.O.B. 454 SE DECISION MADE: 20-MAY-99 GINOT SHOMRON, ISRAEL 44853 510(k) STATEMENT DEVICE: ABBOTT ARCHITECT CEA ABBOTT LABORATORIES, INC. 510(k) NO: K990774(TRADITIONAL) ATTN: KAREN L GATES PHONE NO : 847-938-0538 200 ABBOTT PARK ROAD SE DECISION MADE: 11-MAY-99 ABBOTT PARK, IL 60064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ALCYON DIRECT BILIRUBIN ABBOTT LABORATORIES, INC. 510(k) NO: K991175(TRADITIONAL) ATTN: MARK LITTLEFIELD PHONE NO : 972-518-6062 1920 HURD DR. SE DECISION MADE: 28-MAY-99 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCLAIM INFUSION PUMP ABBOTT LABORATORIES, INC. 510(k) NO: K991501(SPECIAL) ATTN: JILL SACKETT PHONE NO : 847-937-4085 200 ABBOTT PARK ROAD SE DECISION MADE: 13-MAY-99 ABBOTT PARK, IL 60064 510(k) STATEMENT DEVICE: FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES ACC INTL. 510(k) NO: K990729(TRADITIONAL) ATTN: ARTHUR K.K. MA PHONE NO : 626-573-9220 108 N. YNEZ AVE SE DECISION MADE: 13-MAY-99 SUITE 128 510(k) STATEMENT MONTEREY PARK, CA 91754 DEVICE: FLEXNEEDLE PLUS ACT MEDICAL, INC. 510(k) NO: K990693(TRADITIONAL) ATTN: WENDY V SHOTTS PHONE NO : 617-964-9100 150 CALIFORNIA ST. SE DECISION MADE: 14-MAY-99 NEWTON, MA 02458 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS ADVENTURE IN COLORS, INC. 510(k) NO: K984098(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 10-MAY-99 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER ALCON LABORATORIES 510(k) NO: K990480(TRADITIONAL) ATTN: RALPH H LARSEN PHONE NO : 817-551-4702 6201 SOUTH FREEWAY SE DECISION MADE: 10-MAY-99 FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AII-PRO 100 PLUS AND ALL-PRO 200 ALL-PRO IMAGING CORP. 510(k) NO: K991435(TRADITIONAL) ATTN: FREDERICK R FISCHER PHONE NO : 516-433-7676 70 CANTIAGUE ROCK RD. SE DECISION MADE: 20-MAY-99 HICKSVILLE, NY 11801 510(k) STATEMENT DEVICE: AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991484(SPECIAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD., MPWM SE DECISION MADE: 13-MAY-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIBLE VASCULAR CLAMP, VERSION 2 ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991589(SPECIAL) ATTN: PATRICIA SHARPE-GREGG PHONE NO : 847-578-3636 1500 WAUKEGAN RD. SE DECISION MADE: 18-MAY-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWD ALTHIN BIOPHARM, INC. 510(k) NO: K990507(TRADITIONAL) ATTN: JEAN SAURIOL PHONE NO : 450 662 2211 3885 INDUSTRIAL BLVD. SE DECISION MADE: 07-MAY-99 LAVAL, QUEBEC, CANADA H7L 4S3 510(k) STATEMENT DEVICE: PULSEMASTER DENTAL LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC.510(k) NO: K984486(TRADITIONAL) ATTN: JOHN G SULEWSKI PHONE NO : 248-395-3900 18860 WEST TEN MILE ROAD SE DECISION MADE: 13-MAY-99 SOUTHFIELD, MI 48075-2657 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BQ/BM INTEGRATED LASER DELIVERY SYSTEM AMERICAN LASER CORP. 510(k) NO: K990665(TRADITIONAL) ATTN: DANIEL HOEFER PHONE NO : 801-972-1311 2417 SOUTH 3850 WEST SE DECISION MADE: 17-MAY-99 SALT LAKE CITY, UT 84120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBEST OCCULT BLOOD TEST KIT AMERITEK, INC. 510(k) NO: K984269(TRADITIONAL) ATTN: K C YEE PHONE NO : 206-527-5086 7030 35TH AVE., N.E. SE DECISION MADE: 11-MAY-99 SEATTLE, WA 98115 510(k) STATEMENT DEVICE: ATLAST GLUCOSE CONTROL SOLUTION AMIRA MEDICAL, INC. 510(k) NO: K991075(TRADITIONAL) ATTN: NINA PELED PHONE NO : 831-440-5448 4742 SCOTTS VALLEY DR. SE DECISION MADE: 10-MAY-99 SCOTTS VALLEY, CA 95066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM AMPRI RUBBERWARE INDUSTRIES SDN BH510(k) NO: K990812(TRADITIONAL) ATTN: PACK LOON TANG PHONE NO : 603 807 3778 LOT B5 & B6, PHASE II, SE DECISION MADE: 04-MAY-99 KAWASAN PERINDUSTRIAN MIEL 510(k) STATEMENT BATANG KALI, SELANGOR, MALAYSIA 44300 DEVICE: PRE POWDERED LATEX EXAMINATION GLOVES APL PRODUCTS SDN. BHD. 510(k) NO: K990879(TRADITIONAL) ATTN: SON HONG LEE PHONE NO : 605 672 3152 LOT 8961 & 8964, BATU 19 SE DECISION MADE: 17-MAY-99 JALAN BRUAS 510(k) STATEMENT AYER TAWAR, MALAYSIA 32400 DEVICE: POWDER FREE LATEX EXAMINATION GLOVES APL PRODUCTS SDN. BHD. 510(k) NO: K990901(TRADITIONAL) ATTN: SON HONG LEE PHONE NO : 605 672 3152 LOT 8961 & 8964, BATU 19 SE DECISION MADE: 04-MAY-99 JALAN BRUAS 510(k) STATEMENT AYER TAWAR, MALAYSIA 32400 DEVICE: APPLIED BIOTECH SURESTEP DRUG SCREEN MULTI TEST APPLIED BIOTECH, INC. 510(k) NO: K990616(TRADITIONAL) ATTN: JAMES TUNG PHONE NO : 619-587-6771 10237 FLANDERS CT. SE DECISION MADE: 04-MAY-99 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: APPLIED BIOTECH SURESTEP H. PYLORI WB APPLIED BIOTECH, INC. 510(k) NO: K990892(TRADITIONAL) ATTN: JAMES TUNG PHONE NO : 619-587-6771 10237 FLANDERS CT. SE DECISION MADE: 19-MAY-99 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: CYSTIC DUCT BALLOON DILATING CATHETER APPLIED MEDICAL RESOURCES 510(k) NO: K983154(TRADITIONAL) ATTN: HOWARD V ROWE PHONE NO : 949-582-6120 26051 MERIT CIRCLE, #104 SE DECISION MADE: 05-MAY-99 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT ARROW INTL., INC. 510(k) NO: K984022(TRADITIONAL) ATTN: THOMAS D NICKEL PHONE NO : 610-378-0131 2400 BERNVILLE RD. SE DECISION MADE: 18-MAY-99 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR "PTD", MODE ARROW INTL., INC. 510(k) NO: K990829(SPECIAL) ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137 2400 BERNVILLE RD. SE DECISION MADE: 04-MAY-99 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT ARROW INTL., INC. 510(k) NO: K991431(SPECIAL) ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137 2400 BERNVILLE RD. SE DECISION MADE: 26-MAY-99 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS ASAHI MEDICAL CO., LTD. 510(k) NO: K983720(TRADITIONAL) ATTN: DAVID L WEST PHONE NO : 301-548-0504 15825 SHADY GROVE ROAD, SE DECISION MADE: 17-MAY-99 SUITE 90 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K ASTORIA-PACIFIC,INC. 510(k) NO: K990957(TRADITIONAL) ATTN: RAYMOND L PAVITT PHONE NO : 503-657-3010 14600 S.E. 82ND DR. SE DECISION MADE: 11-MAY-99 CLAKAMAS, OR 97015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN ATRIUM MEDICAL CORP. 510(k) NO: K984496(TRADITIONAL) ATTN: JOSEPH P DEPAOLO PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 05-MAY-99 HUDSON, NH 03051 510(k) STATEMENT DEVICE: BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME BALLARD MEDICAL PRODUCTS 510(k) NO: K990376(TRADITIONAL) ATTN: E. MARTIN CHAMBERLAIN PHONE NO : 801-572-6800 12050 LONE PEAK PKWY. SE DECISION MADE: 03-MAY-99 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES BARRIERMED GLOVE CO. 510(k) NO: K990710(TRADITIONAL) ATTN: CARLO PONCIPE PHONE NO : 407-323-1604 2500 WEST LAKE MARY BLVD. SE DECISION MADE: 20-MAY-99 LAKE MARY, FL 32746 510(k) STATEMENT DEVICE: THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN V BAYER CORP. 510(k) NO: K983715(TRADITIONAL) ATTN: GABRIEL J MURACA, JR. PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 14-MAY-99 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP. 510(k) NO: K990346(TRADITIONAL) ATTN: GABRIEL J MURACA, JR. PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 21-MAY-99 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT BECKMAN COULTER, INC. 510(k) NO: K990704(TRADITIONAL) ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767 200 SOUTH KRAEMER BLVD.,W-337 SE DECISION MADE: 03-MAY-99 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FALCON IVF FOUR WELL PLATE BECTON DICKINSON LABWARE 510(k) NO: K991249(TRADITIONAL) ATTN: DAVID BALL PHONE NO : 408-954-2694 1 BECTON DR. SE DECISION MADE: 05-MAY-99 FRANKLIN LAKES, NJ 07465-1886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FALCON IVF ONE WELL DISH BECTON DICKINSON LABWARE 510(k) NO: K991251(TRADITIONAL) ATTN: DAVID BALL PHONE NO : 408-954-2694 1 BECTON DR. SE DECISION MADE: 05-MAY-99 FRANKLIN LAKES, NJ 07465-1886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FALCON IVF ROUND DISH BECTON DICKINSON LABWARE 510(k) NO: K991253(TRADITIONAL) ATTN: DAVID BALL PHONE NO : 408-954-2694 1 BECTON DR. SE DECISION MADE: 05-MAY-99 FRANKLIN LAKES, NJ 07465-1886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION BECTON DICKINSON VACUTAINER SYSTEM510(k) NO: K991088(TRADITIONAL) ATTN: ANDREA HRONCICH PHONE NO : 201-847-6173 ONE BECTON DR. SE DECISION MADE: 28-MAY-99 FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUTAINER BRAND CTAD TUBE (MULTIPLE) BECTON DICKINSON VACUTAINER SYSTEM510(k) NO: K991120(TRADITIONAL) ATTN: JAMES W HAYNES PHONE NO : 201-847-5170 1 BECTON DR. SE DECISION MADE: 19-MAY-99 FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHROMOPHARE D500, D530, D650 BERCHTOLD GMBH & CO. 510(k) NO: K991527(SPECIAL) ATTN: WOLFRAM K HILL PHONE NO : 004 974 61181370 LUDWIGSTALER STR. 25 SE DECISION MADE: 27-MAY-99 TUTTLINGEN, GERMANY D-78505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF:BIODERM FOAM WOUND DRESSING BIODERM, INC. 510(k) NO: K990955(TRADITIONAL) ATTN: GEORGE WORTHLEY PHONE NO : 630-690-8339 P.O. BOX 4882 SE DECISION MADE: 18-MAY-99 WHEATON, IL 60189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONE MULCH SCREW SYSTEM BIOMET, INC. 510(k) NO: K991298(TRADITIONAL) ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 14-MAY-99 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENT KNEE SYSTEM BIOMET, INC. 510(k) NO: K991428(SPECIAL) ATTN: DALENE HUFZIGER BINKLEY PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 21-MAY-99 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-SCAN BIOSOUND ESAOTE, INC. 510(k) NO: K990968(TRADITIONAL) ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793 8000 CASTLEWAY DR. SE DECISION MADE: 27-MAY-99 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTORVISION2 BRAINLAB GMBH 510(k) NO: K983831(TRADITIONAL) ATTN: PHONE NO : 3100 HANSEN WAY SE DECISION MADE: 19-MAY-99 BUILDING 4A, MAILSTOP E233 510(k) STATEMENT PALO ALTO, CA 94304 DEVICE: BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE BRAINMASTER 510(k) NO: K990538(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-MAY-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990878(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 21-MAY-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMAL BUSINESS SUPPORT INTL. 510(k) NO: K991324(TRADITIONAL) ATTN: DAGMAR S MASER PHONE NO : 011 312 04289591 AMSTEL 320-I SE DECISION MADE: 18-MAY-99 AMSTERDAM, NETHERLANDS 1017-AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACER O-T-W MAPPING DEVICE CARDIMA, INC. 510(k) NO: K972803(TRADITIONAL) ATTN: SHELLEY TRIMM PHONE NO : 510-354-0300 47266 BENICIA ST. SE DECISION MADE: 11-MAY-99 FREMONT, CA 94538-1372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAS ANALYZER, MODEL 1009 CARDIOVASCULAR DIAGNOSTICS, INC. 510(k) NO: K990566(TRADITIONAL) ATTN: PETER SCOTT PHONE NO : 919-874-6103 5301 DEPARTURE DR. SE DECISION MADE: 14-MAY-99 RALEIGH, NC 27616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC. 510(k) NO: K990239(TRADITIONAL) ATTN: LYNNE LEONARD PHONE NO : 303-467-6586 14401 WEST 65TH WAY SE DECISION MADE: 25-MAY-99 ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVUS VERDI DELIVERY SYSTEMS COHERENT, INC. 510(k) NO: K991258(TRADITIONAL) ATTN: KATHY A MAYNOR PHONE NO : 408-764-3266 2400 CONDENSA ST. SE DECISION MADE: 13-MAY-99 SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOGRAM BONE DENSITOMETER COMPUMED, INC. 510(k) NO: K984285(TRADITIONAL) ATTN: T WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY SE DECISION MADE: 19-MAY-99 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. 510(k) NO: K991635(SPECIAL) ATTN: DAVID U THOMAS PHONE NO : 805-685-3729 130 CREMONA DRIVE, SUITE B SE DECISION MADE: 27-MAY-99 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES CONMED CORP. 510(k) NO: K990586(TRADITIONAL) ATTN: IRA D DUESLER PHONE NO : 315-797-8375 310 BROAD ST. SE DECISION MADE: 17-MAY-99 UTICA, NY 13501-1203 510(k) STATEMENT DEVICE: CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY CONTINENTAL SOFT LENS, INC. 510(k) NO: K990011(TRADITIONAL) ATTN: KIM MCQUARRIE PHONE NO : 303-795-2130 10 GLENVIEW DR. SE DECISION MADE: 11-MAY-99 LITTLETON, CO 80123 510(k) STATEMENT DEVICE: SIGNADRESS DUODERM DRESSING CONVATEC, A DIVISION OF E.R. SQUIB510(k) NO: K990964(TRADITIONAL) ATTN: NANCY L WOLLEY PHONE NO : 908-281-2571 100 HEADQUARTERS PARK DRIVE SE DECISION MADE: 18-MAY-99 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER COOK, INC. 510(k) NO: K990753(TRADITIONAL) ATTN: APRIL LAVENDER PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 27-MAY-99 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS TEMPO ANGIOGRAPHY CATHETER CORDIS CORP. 510(k) NO: K991673(SPECIAL) ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332 14201 N.W. 60TH AVE. SE DECISION MADE: 26-MAY-99 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER Z2 ANALYZER COULTER CORP. 510(k) NO: K991070(TRADITIONAL) ATTN: THOMAS J ENGLISH PHONE NO : 305-380-4331 1950 WEST 8TH AVE. SE DECISION MADE: 11-MAY-99 HIALEAH, FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF N/T PROTEIN CONTROL SL DADE BEHRING, INC. 510(k) NO: K991182(TRADITIONAL) ATTN: CAROLYN K GEORGE PHONE NO : 781-826-2073 P.O. BOX 6101 SE DECISION MADE: 19-MAY-99 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. 510(k) NO: K983408(TRADITIONAL) ATTN: SHAROLYN J LENTSCH PHONE NO : 916-374-3183 1584 ENTERPRISE BLVD. SE DECISION MADE: 10-MAY-99 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR DANEK MEDICAL, INC. 510(k) NO: K991528(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 28-MAY-99 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998- DATASCOPE CORP. 510(k) NO: K983575(TRADITIONAL) ATTN: RUSSELL OLSEN PHONE NO : 201-967-6894 580 WINTERS AVE. SE DECISION MADE: 13-MAY-99 PARAMUS, NJ 07653 510(k) STATEMENT DEVICE: STARDENTAL AXCS STERILE WATER SYSTEM DEN-TAL-EZ, INC. 510(k) NO: K990844(TRADITIONAL) ATTN: FRANK OELLIG PHONE NO : 717-291-1161 1816 COLONIAL VILLAGE LN. SE DECISION MADE: 28-MAY-99 LANCASTER, PA 17601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DMD DIGITAL X-RAY SYSTEM DENTAL/MEDICAL DIAGNOSTIC SYSTEMS,510(k) NO: K990087(TRADITIONAL) ATTN: STEVE BRODY PHONE NO : 949-756-1770 16722 MILLIKAN AVE. SE DECISION MADE: 13-MAY-99 IRVINE, CA 92606 510(k) STATEMENT DEVICE: MANOMETRIC ASSEMBLIES DENTSLEEVE PTY., LTD. 510(k) NO: K983665(TRADITIONAL) ATTN: MARCUS TIPPETT PHONE NO : 618 827 10744 56 A/B GLEN OSMOND RD. SE DECISION MADE: 17-MAY-99 PARKSIDE, SOUTH AUSTRALIA, AUSTRAL510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING DERMAPHYLYX, INC. 510(k) NO: K990875(TRADITIONAL) ATTN: ANDREW M REED PHONE NO : 303-431-6796 12106, WEST 75TH LANE SE DECISION MADE: 27-MAY-99 ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WO DERMAPHYLYX, INC. 510(k) NO: K990891(TRADITIONAL) ATTN: ANDREW M REED PHONE NO : 303-431-6796 12106, WEST 75TH LANE SE DECISION MADE: 27-MAY-99 ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PELVX INCONTINENCE DISH, MODEL 301-306 DESCHUTES MEDICAL PRODUCTS, INC. 510(k) NO: K990593(TRADITIONAL) ATTN: DENISE BESTWICK PHONE NO : 541-385-0350 1011 S.W. EMKAY DR., SUITE 104 SE DECISION MADE: 24-MAY-99 BEND, OR 97702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K991094(SPECIAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 13-MAY-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K991096(SPECIAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 13-MAY-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COPALIS EBV-M ANTIBODY ASSAY DIASORIN INC. 510(k) NO: K991459(TRADITIONAL) ATTN: JUDITH J SMITH PHONE NO : 651-439-9710 9175 GUIFORD ROAD SE DECISION MADE: 14-MAY-99 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IONOSIT BOND DMG CHEMISCH PHARMAZEUTISCHE FABRI510(k) NO: K991172(TRADITIONAL) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 17-MAY-99 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) DONGKUK TECHCO RUBBER INDUSTRIES S510(k) NO: K990669(ABBREVIATED) ATTN: PETER PARK PHONE NO : 604 261 0600 7TH FL. MAYBAN TRUST BLDG. SE DECISION MADE: 17-MAY-99 3 PENANG ST. 510(k) STATEMENT PENANG, MALAYSIA 10200 DEVICE: EASTGATE PERSONAL MONITOR EASTGATE TRADING CORP. 510(k) NO: K990731(TRADITIONAL) ATTN: MORRIS CORN PHONE NO : 212-947-8388 990 AVE. OF AMERICAS, #15D SE DECISION MADE: 19-MAY-99 NEW YORK, NY 10084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDGE SYSTEMS STERILE TUBING EDGE SYSTEMS CORP. 510(k) NO: K990748(TRADITIONAL) ATTN: GARY MOCNIK PHONE NO : 949-363-2953 30001 GOLDEN LANTERN # 334 SE DECISION MADE: 04-MAY-99 LAGUNA NIGUEL, CA 92677 510(k) STATEMENT DEVICE: ELAN ALKALINE PHOSPHATE REAGENT KIT ELAN HOLDINGS, INC. 510(k) NO: K991387(TRADITIONAL) ATTN: RALPH BOLSTAD PHONE NO : 800-733-4424 231 NORTH PUENTE ST. SE DECISION MADE: 19-MAY-99 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 ELEKTA INSTRUMENT AB 510(k) NO: K984328(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 619-451-0642 18140 SMOKESIGNAL DRIVE SE DECISION MADE: 21-MAY-99 SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLENNIUM ENDO TECHNIC CORP. 510(k) NO: K990908(TRADITIONAL) ATTN: ANDREW I KIMMEL PHONE NO : 949-361-3545 981 CALLE AMANECER SE DECISION MADE: 27-MAY-99 (MOVED FROM BOS/DO TO LA/DOS) 510(k) SUMMARY AVAILABLE FROM FDA SAN CLEMENTE, CA 92680 DEVICE: VITRON M ESPE DENTAL AG 510(k) NO: K990763(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 25-MAY-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITRON H ESPE DENTAL AG 510(k) NO: K991220(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 498 152 7001395 ESPE PLATZ SE DECISION MADE: 20-MAY-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VESTOGUM ESPE DENTAL AG 510(k) NO: K991221(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 498 152 7001395 ESPE PLATZ SE DECISION MADE: 20-MAY-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES ETHICON ENDO-SURGERY, INC. 510(k) NO: K991030(TRADITIONAL) ATTN: EDWIN O BILLIPS PHONE NO : 513-786-7162 4545 CREEK ROAD SE DECISION MADE: 17-MAY-99 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALLINI ATRA-CUT NEEDLE GALLINI U.S., LLC 510(k) NO: K990645(TRADITIONAL) ATTN: PAUL L HAWTHORNE PHONE NO : 804-261-1601 3991 GLENSIDE DR., SUITE F SE DECISION MADE: 19-MAY-99 RICHMOND, VA 23229 510(k) STATEMENT DEVICE: GALLINI BYCUT NEEDLE GALLINI U.S., LLC 510(k) NO: K990716(TRADITIONAL) ATTN: PAUL L HAWTHORNE PHONE NO : 804-261-1601 3991 GLENSIDE DR., SUITE F SE DECISION MADE: 17-MAY-99 RICHMOND, VA 23229 510(k) STATEMENT DEVICE: GC RELINE SOFT/EXTRA SOFT GC AMERICA, INC. 510(k) NO: K990736(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-587-0900 3737 WEST 127TH STREET SE DECISION MADE: 28-MAY-99 ALSIP, IL 60803 510(k) STATEMENT DEVICE: 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS, INC. 510(k) NO: K990550(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 414-544-3894 P.O. BOX 414, W-709 SE DECISION MADE: 11-MAY-99 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY GERMAINE LABORATORIES, INC. 510(k) NO: K991369(TRADITIONAL) ATTN: MARTIN O'CONNOR PHONE NO : 210-692-4192 4203 GARDENDALE CENTER, #230 SE DECISION MADE: 10-MAY-99 SAN ANTONIO, TX 78229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN GLOVCO (M) SDN. BHD. 510(k) NO: K991043(TRADITIONAL) ATTN: TAN PENG HOCK PHONE NO : 603 391 3888 LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 04-MAY-99 OFF JALAN MERU 510(k) STATEMENT KLANG, SELANGOR D.E., MALAYSIA 42100 DEVICE: STAPES PROSTHESES GRACE MEDICAL, INC. 510(k) NO: K991394(SPECIAL) ATTN: ANTHONY D PRESCOTT PHONE NO : 901-386-0990 7731 HIGHWAY 70, SUITE 107 SE DECISION MADE: 18-MAY-99 BARTLETT, TN 38133 510(k) STATEMENT DEVICE: GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM GREAT SMOKIES DIAGNOSTIC LABORATOR510(k) NO: K991156(TRADITIONAL) ATTN: STEPHEN BARRIE PHONE NO : 800-522-4762 63 ZILLICOA ST. SE DECISION MADE: 28-MAY-99 ASHEVILLE, NC 28801-1074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHO-GLOW GLITTER HARRY J. BOSWORTH CO. 510(k) NO: K990699(TRADITIONAL) ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 17-MAY-99 SKOKIE, IL 60076 510(k) STATEMENT DEVICE: SMARTPREP CENTRIFUGE SYSTEM HARVEST TECHNOLOGIES, LLC 510(k) NO: K991430(TRADITIONAL) ATTN: RICK LARIVIERE PHONE NO : 781-982-1900 77 ACCORD PARK DR., D-7 SE DECISION MADE: 28-MAY-99 NORWELL, MA 02061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOW LINE HERAEUS KULZER, INC. 510(k) NO: K990756(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 07-MAY-99 SOUTH BEND, IN 46614-2517 510(k) STATEMENT DEVICE: HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NA HITACHI MEDICAL CORP. OF AMERICA 510(k) NO: K991129(TRADITIONAL) ATTN: GARY W ENOS PHONE NO : 330-405-3330 9177 DUTTON DR. SE DECISION MADE: 13-MAY-99 TWINSBURG, OH 44056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HITACHI VERSIFLEX HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K991231(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY, SE DECISION MADE: 24-MAY-99 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INS HOWMEDICA OSTEONICS CORP. 510(k) NO: K991461(SPECIAL) ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376 59 ROUTE 17 SE DECISION MADE: 17-MAY-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD HURRICANE MEDICAL 510(k) NO: K990671(TRADITIONAL) ATTN: DAVID A CLAPP PHONE NO : 941-751-0588 2331K 63RD AVE. EAST SE DECISION MADE: 10-MAY-99 BRADENTON, FL 34203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET HURRICANE MEDICAL 510(k) NO: K990672(TRADITIONAL) ATTN: DAVID A CLAPP PHONE NO : 941-751-0588 2331K 63RD AVE. EAST SE DECISION MADE: 18-MAY-99 BRADENTON, FL 34203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER IDEM (INT'L DIST. OF ELECTRONICS F510(k) NO: K990585(TRADITIONAL) ATTN: DONNA WARD PHONE NO : 800-947-6334 4814 EAST SECOND STREET SE DECISION MADE: 17-MAY-99 BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER IDEM (INT'L DIST. OF ELECTRONICS F510(k) NO: K990652(TRADITIONAL) ATTN: DONNA WARD PHONE NO : 800-947-6334 4814 EAST SECOND STREET SE DECISION MADE: 17-MAY-99 BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTE IMMEDICA, INC. 510(k) NO: K990848(TRADITIONAL) ATTN: ROY BOGERT PHONE NO : 973-635-9040 100 PASSAIC AVE. SE DECISION MADE: 17-MAY-99 CHATHAM, NJ 07928-2848 510(k) STATEMENT DEVICE: LAMINOSS DENTAL IMPLANT IMPLADENT, LTD. 510(k) NO: K982925(TRADITIONAL) ATTN: MAURICE VALEN PHONE NO : 718-465-1810 198-45 FOOTHILL AVE. SE DECISION MADE: 18-MAY-99 HOLLISWOOD, NY 11423 510(k) STATEMENT DEVICE: IODINE BRACHYTHERAPY SEEDS, MODEL 3000 IMPLANT SCIENCES CORP. 510(k) NO: K990193(TRADITIONAL) ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510 107 AUDUBON ROAD, #5 SE DECISION MADE: 20-MAY-99 WAKEFIELD, MA 01880-1246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 F IMPLEMED, INC. 510(k) NO: K990509(ABBREVIATED) ATTN: ANTHONY L BLANK PHONE NO : 617-923-6375 313 PLEASANT ST. SE DECISION MADE: 18-MAY-99 WATERTOWN, MA 02172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRIT-SCAN II MONITOR IN-LINE DIAGNOSTICS CORP. 510(k) NO: K983551(TRADITIONAL) ATTN: MATTHEW L HAYNIE PHONE NO : 801-451-9000 117 WEST 200 SOUTH SE DECISION MADE: 27-MAY-99 FARMINGTON, UT 84025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSURE PREGNANCY TEST INBIOS INTL., INC. 510(k) NO: K991515(TRADITIONAL) ATTN: ESTELA I RAYCHAUDHURI PHONE NO : 206-344-5821 562 1ST. AVE. SOUTH, SUITE 600 SE DECISION MADE: 28-MAY-99 SEATTLE, WA 98104 510(k) STATEMENT DEVICE: INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE INNERDYNE, INC. 510(k) NO: K990493(TRADITIONAL) ATTN: RICK GAYKOWSKI PHONE NO : 801-350-3600 5060 WEST AMELIA EARHART DR. SE DECISION MADE: 18-MAY-99 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KERATOME SYSTEM, MODEL K3000 INSIGHT TECHNOLOGIES INSTRUMENTS, 510(k) NO: K984537(TRADITIONAL) ATTN: CHARLES VASSALLO PHONE NO : 203-876-3481 264 QUARRY ROAD SE DECISION MADE: 14-MAY-99 MILFORD, CT 06460 510(k) STATEMENT DEVICE: BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL INTEGRA NEUROCARE LLC 510(k) NO: K981246(TRADITIONAL) ATTN: LORI HAYS PHONE NO : 800-997-4868 8401 102ND ST., SUITE 200 SE DECISION MADE: 26-MAY-99 PLEASANT PRAIRIE, WI 53158-0390 510(k) STATEMENT DEVICE: MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM INTERNATIONAL MEDICAL SYSTEMS 510(k) NO: K990515(TRADITIONAL) ATTN: PHONE NO : PO BOX 4936 SE DECISION MADE: 13-MAY-99 ANNAPOLIS, MD 21403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOCHRON RESPONSE INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K983475(TRADITIONAL) ATTN: JOHN M CLAY PHONE NO : 732-548-5700 8 OLSEN AVENUE SE DECISION MADE: 03-MAY-99 EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) ITL CORPORATION, PTY LTD. 510(k) NO: K991404(TRADITIONAL) ATTN: KENNETH A PALMER PHONE NO : 301-548-0508 15825 SHADY GROVE ROAD SE DECISION MADE: 14-MAY-99 SUITE 90 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: K-ASSAY CRP CALIBRATOR SET KAMIYA BIOMEDICAL CO. 510(k) NO: K991210(TRADITIONAL) ATTN: COLIN GETTY PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 11-MAY-99 SEATTLE, WA 98188-3412 510(k) STATEMENT DEVICE: K-ASSAY CRP KAMIYA BIOMEDICAL CO. 510(k) NO: K991224(TRADITIONAL) ATTN: COLIN GETTY PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 14-MAY-99 SEATTLE, WA 98188-3412 510(k) STATEMENT DEVICE: MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE KARL STORZ ENDOSCOPY 510(k) NO: K990411(TRADITIONAL) ATTN: KEVIN A KENNAN PHONE NO : 310-558-1500 600 CORPORATE POINTE SE DECISION MADE: 11-MAY-99 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCITONIN KMI DIAGNOSTICS, INC. 510(k) NO: K990073(TRADITIONAL) ATTN: GOTTFRIED KELLERMAN PHONE NO : 715-294-2144 373 280TH STREET SE DECISION MADE: 11-MAY-99 OSCEOLA, WI 54020 510(k) STATEMENT DEVICE: WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHO LA MONT MEDICAL, INC. 510(k) NO: K990522(TRADITIONAL) ATTN: TONY MONTGOMERY PHONE NO : 608-827-9000 555 D'ONOFRIO DR. SE DECISION MADE: 19-MAY-99 MADISON, WI 53719-2053 510(k) STATEMENT DEVICE: LACTATION TECHNIQUES MODEL B LACTATION TECHNIQUES INC. 510(k) NO: K981549(TRADITIONAL) ATTN: MARK LELOUDIS PHONE NO : 801-972-7026 1252 WEST 50 SOUTH SE DECISION MADE: 24-MAY-99 SALT LAKE CITY, UT 84014 510(k) STATEMENT DEVICE: LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE) LAGLOVE (M) SDN. BHD. 510(k) NO: K990882(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 5411 JALAN SIMPANG BALAK, OFF BATU SE DECISION MADE: 21-MAY-99 13, JALAN CHERAS, 43000 KAJANG 510(k) STATEMENT SELANGOR DARUL EHSAN MALA, MADAGASCAR DEVICE: QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED LATEXX PARTNERS BHD. 510(k) NO: K991462(TRADITIONAL) ATTN: CHONG ENG LIM PHONE NO : 605 891 5555 PT. 5054, KAMUNTING IND ESTATE SE DECISION MADE: 28-MAY-99 P.O. BOX 9 510(k) SUMMARY AVAILABLE FROM FDA KAMUNTING, PERAK, MALAYSIA 34600 DEVICE: LIFE IMAGING SYSTEMS, MODEL L3DI LIFE IMAGING SYSTEMS, INC. 510(k) NO: K990560(TRADITIONAL) ATTN: KEVIN MORNINGSTAR PHONE NO : 303-697-8198 PO BOX 218 SE DECISION MADE: 20-MAY-99 INDIAN HILLS, CO 80454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESTEP BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. 510(k) NO: K984261(TRADITIONAL) ATTN: ROGER THIES PHONE NO : 202-736-5600 700 THIRTEENTH STREET NW SE DECISION MADE: 21-MAY-99 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROGAS 7650 TRANSCUTANEOUS MONITOR LINDE MEDICAL SENSORS AG 510(k) NO: K991644(SPECIAL) ATTN: ALEX STENZLER PHONE NO : 800-520-4368 AUSTRASSE 25 SE DECISION MADE: 21-MAY-99 BASEL, SWITZERLAND 4051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOV LONDON INTERNATIONAL GROUP INC. 510(k) NO: K984249(TRADITIONAL) ATTN: NEIL ANDERSON PHONE NO : 334-702-2231 P.O. BOX 8308 SE DECISION MADE: 04-MAY-99 2926 COLUMBIA HIGHWAY 510(k) STATEMENT DOTHAN, AL 36304 DEVICE: BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES LONG FIRST (XIAMEN) CO.,LTD. 510(k) NO: K990946(TRADITIONAL) ATTN: STONE CHEN PHONE NO : 886 075 612201 #23, KOOSHAN 3RD ROAD, SE DECISION MADE: 04-MAY-99 KAOHSIUNG, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES LONG FIRST (XIAMEN) CO.,LTD. 510(k) NO: K991085(TRADITIONAL) ATTN: STONE CHEN PHONE NO : 886 075 612201 #23, KOOSHAN 3RD ROAD, SE DECISION MADE: 05-MAY-99 KAOHSIUNG, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES M.R.G. INDUSTRIES BERHAD 510(k) NO: K991640(TRADITIONAL) ATTN: LIM CHONG PHONE NO : 605 891 1111 PT. 4004, JALAN PERUSAHAAN 3 SE DECISION MADE: 28-MAY-99 KAMUNTING INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA KAMUNTING, TAIPING, PERAK, MALAYSIA 34600 DEVICE: BLUE POWDER-FREE NITRILE EXAMINATION GLOVES MASJU SDN. BHD. 510(k) NO: K991493(TRADITIONAL) ATTN: HENG CHENG HUI PHONE NO : 044 388 518 PLOT 3, JALAN 1, TIKAM BATU SE DECISION MADE: 26-MAY-99 SUNGAI PETANI, MALAYSIA 08600 510(k) STATEMENT DEVICE: SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES MAXXIM MEDICAL, INC. 510(k) NO: K983982(ABBREVIATED) ATTN: PETER GRAHAM PHONE NO : 727-561-2100 4750 118TH AVE. NORTH SE DECISION MADE: 04-MAY-99 CLEARWATER, FL 34622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER MAXXIM MEDICAL, INC. 510(k) NO: K984189(TRADITIONAL) ATTN: EDDIE MONROE PHONE NO : 903-675-9321 1445 FLAT CREEK RD. SE DECISION MADE: 05-MAY-99 ATHENS, TX 75751 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRU-CORE I REUSABLE BIOPSY INSTRUMENT MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K990839(TRADITIONAL) ATTN: KARL SWARTZ PHONE NO : 352-338-0440 4600 S.W. 47TH AVE. SE DECISION MADE: 20-MAY-99 GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF MLT R694 RUBY LASER SYSTEM MEDICAL LASER TECHNOLOGIES LTD. 510(k) NO: K990902(TRADITIONAL) ATTN: DAVID HAMILTON PHONE NO : 011 441 383411555 UNIT 15,BELLEKNOWES INDUSTRIAL SE DECISION MADE: 27-MAY-99 ESTATE 510(k) SUMMARY AVAILABLE FROM FDA INVERKEITHING,FIFE, UNITED KINGDOM KY11 1HY DEVICE: INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY MEDTECH LTD. 510(k) NO: K990663(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 13TH STREET N.W. SE DECISION MADE: 27-MAY-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ULTRA-SELECT GUIDEWIRE MICROVENA CORP. 510(k) NO: K991194(SPECIAL) ATTN: ANGELA MALLERY PHONE NO : 651-777-6700 1861 BUERKLE RD. SE DECISION MADE: 05-MAY-99 WHITE BEAR LAKE, MN 55110-5246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M CLINPRO PROPHY PASTE, MODEL 12611 MINNESOTA MINING AND MFG. CO. 510(k) NO: K990482(TRADITIONAL) ATTN: REBECCA L HANNACK PHONE NO : 651-737-1105 3M CENTER, BUILDING 260-2B-12 SE DECISION MADE: 13-MAY-99 ST. PAUL, MN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBC, DONG BANG ACUPUNCTURE NEEDLES MORNING STAR, DONG BANG ACUPUNCTUR510(k) NO: K990328(TRADITIONAL) ATTN: AE-HOE KWON PHONE NO : 626-403-5959 1429 LYNDON ST. SE DECISION MADE: 04-MAY-99 SOUTH PASADENA, CA 91030-3811 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR NEAL DUNNING ASSOC., INC. 510(k) NO: K990479(TRADITIONAL) ATTN: NEAL DUNNING PHONE NO : 301-122-9213 8309 BRYANT DR. SE DECISION MADE: 13-MAY-99 BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM OLYMPUS AMERICA, INC. 510(k) NO: K991136(TRADITIONAL) ATTN: LAURA STORMS TYLER PHONE NO : 516-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 11-MAY-99 MELVILLE, NY 11747-3157 510(k) STATEMENT DEVICE: OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE OMNIGRACE (THAILAND) LTD. 510(k) NO: K990695(TRADITIONAL) ATTN: K.C. CHOONG PHONE NO : 667 443 9526 641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 04-MAY-99 TAMBON BANPRU 510(k) STATEMENT HATYAI, SONGKHLA, THAILAND 90250 DEVICE: OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE OMNIGRACE (THAILAND) LTD. 510(k) NO: K990696(TRADITIONAL) ATTN: K.C. CHOONG PHONE NO : 667 443 9526 641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 13-MAY-99 TAMBON BANPRU 510(k) STATEMENT HATYAI, SONGKHLA, THAILAND 90250 DEVICE: OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE OMNIGRACE (THAILAND) LTD. 510(k) NO: K990698(TRADITIONAL) ATTN: K.C. CHOONG PHONE NO : 667 443 9526 641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 13-MAY-99 TAMBON BANPRU 510(k) STATEMENT HATYAI, SONGKHLA, THAILAND 90250 DEVICE: OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE OMNIGRACE (THAILAND) LTD. 510(k) NO: K990701(TRADITIONAL) ATTN: K.C. CHOONG PHONE NO : 667 443 9526 641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 05-MAY-99 TAMBON BANPRU 510(k) STATEMENT HATYAI, SONGKHLA, THAILAND 90250 DEVICE: OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED OMNIGRACE (THAILAND) LTD. 510(k) NO: K990702(TRADITIONAL) ATTN: K.C. CHOONG PHONE NO : 667 443 9526 641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 04-MAY-99 TAMBON BANPRU 510(k) STATEMENT HATYAI, SONGKHLA, THAILAND 90250 DEVICE: ORALGIENE TONGUE CLEANER ORALGIENE USA, INC. 510(k) NO: K990344(TRADITIONAL) ATTN: BILL MUCKLEROY PHONE NO : 310-204-7888 8460 HIGUERA ST. SE DECISION MADE: 04-MAY-99 CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE ORATEC INTERVENTIONS, INC. 510(k) NO: K990474(TRADITIONAL) ATTN: SHEILA RAMERMAN PHONE NO : 650-687-3475 3700 HAVEN CT. SE DECISION MADE: 17-MAY-99 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 ORIENTAL SYSTEM TECHNOLOGY INC. 510(k) NO: K984497(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD SE DECISION MADE: 26-MAY-99 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS I ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K983875(TRADITIONAL) ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790 100 INDIGO CREEK DR. SE DECISION MADE: 14-MAY-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990016(TRADITIONAL) ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790 100 INDIGO CREEK DRIVE SE DECISION MADE: 19-MAY-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTRAFIX EXTERNAL FIXATOR OWANDAR MEDICAL LTD 510(k) NO: K991732(TRADITIONAL) ATTN: JOHN RADWELL PHONE NO : 014 944 84250 PO BOX 389 SE DECISION MADE: 21-MAY-99 HIGH WYCOMBE 510(k) SUMMARY AVAILABLE FROM FDA HP14 3XP, UNITED KINGDOM DEVICE: SYNERGY IOM SYSTEM OXFORD INSTRUMENTS MEDICAL SYSTEMS510(k) NO: K984052(TRADITIONAL) ATTN: E J SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 17-MAY-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL, P. T. TATA RUBBERINDO INDUSTRIES 510(k) NO: K991158(TRADITIONAL) ATTN: EMMY TJOENG PHONE NO : 626-913-1798 889 SOUTH AZUSA AVENUE SE DECISION MADE: 28-MAY-99 INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOTALBOND PARKELL PRODUCTS, INC. 510(k) NO: K990381(TRADITIONAL) ATTN: NELSON J GENDUSA PHONE NO : 516-249-1134 155 SCHMITT BLVD. SE DECISION MADE: 17-MAY-99 FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTEMP PARKELL PRODUCTS, INC. 510(k) NO: K991270(TRADITIONAL) ATTN: NELSON J GENDUSA PHONE NO : 516-249-1134 155 SCHMITT BLVD. SE DECISION MADE: 21-MAY-99 FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, PHARMACIA & UPJOHN CO. 510(k) NO: K991048(TRADITIONAL) ATTN: KAREN E MATIS PHONE NO : 614-794-3324 5094 ST. ANDREWS DRIVE SE DECISION MADE: 14-MAY-99 WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS TOMOSCAN AV-NT PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K991278(TRADITIONAL) ATTN: FRANK GIANELLI PHONE NO : 203-926-7729 710 BRIDGEPORT AVENUE SE DECISION MADE: 13-MAY-99 P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA SHELTON, CT 06484-0197 DEVICE: PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K990455(TRADITIONAL) ATTN: FRANK GIANELLI PHONE NO : 203-926-7729 710 BRIDGEPORT AVENUE SE DECISION MADE: 12-MAY-99 SHELTON, CT 06484-4708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMOND II VALVE PHOENIX BIOMEDICAL CORP. 510(k) NO: K991429(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 19-MAY-99 NORRISTOWN, PA 19403 510(k) STATEMENT DEVICE: LIFEPAK 500 BIPHASIC PHYSIO-CONTROL CORP. 510(k) NO: K983393(TRADITIONAL) ATTN: SHERRI L POCOCK PHONE NO : 425-867-4332 11811 WILLOWS RD., N.E. SE DECISION MADE: 05-MAY-99 REDMOND, WA 98073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICAL FORCEPS PILLING WECK SURGICAL 510(k) NO: K990561(TRADITIONAL) ATTN: ELIZABETH LAZARO PHONE NO : 800-523-6507 420 DELAWARE DR. SE DECISION MADE: 14-MAY-99 FORT WASHINGTON, PA 19034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JACKSON ESOPHAGEAL DILATOR PILLING WECK SURGICAL 510(k) NO: K990935(TRADITIONAL) ATTN: ELIZABETH LAZARO PHONE NO : 800-523-6507 420 DELAWARE DR. SE DECISION MADE: 17-MAY-99 FORT WASHINGTON, PA 19034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BERACLAMP, MODEL BC-1 POAMAX L.L.C. 510(k) NO: K990045(TRADITIONAL) ATTN: MICHAEL J PALMER PHONE NO : 757-868-9865 17 ALPHUS ST. SE DECISION MADE: 24-MAY-99 POGUOSON, VA 23662 510(k) STATEMENT DEVICE: MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K990247(TRADITIONAL) ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610 7736 ZIONSVILLE ROAD SE DECISION MADE: 28-MAY-99 INDIANAPOLIS, IN 46268 510(k) STATEMENT DEVICE: APOLLO 5, APOLLO 10 PRECITRON A.B. 510(k) NO: K990383(TRADITIONAL) ATTN: KJELL WESTERLUND PHONE NO : 461 830 0690 ULTUNAALLEN 2 SE DECISION MADE: 05-MAY-99 UPPSALA, SWEDEN S-756 51 510(k) STATEMENT DEVICE: MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TE PRINCETON BIOMEDITECH CORP. 510(k) NO: K991299(TRADITIONAL) ATTN: JEMO KANG PHONE NO : 732-274-1000 4242 U.S. RT. 1 SE DECISION MADE: 28-MAY-99 MONMOUTH JUNCTION, NJ 08852-1905 510(k) STATEMENT DEVICE: ROCS ULTRASEED RADIATION ONCOLOGY COMPUTER SYSTEM510(k) NO: K984241(TRADITIONAL) ATTN: CHARLENE NEBLETT PHONE NO : 760-929-1811 6190 CORTE DEL CEDRO SE DECISION MADE: 12-MAY-99 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLOUD 1 HUMIDIFICATION SYSTEM RESPIRATORY SUPPORT PRODUCTS, INC.510(k) NO: K983862(TRADITIONAL) ATTN: GORDON SHIGEZAWA PHONE NO : 949-756-2250 2552 MCGRAW AVENUE SE DECISION MADE: 24-MAY-99 IRVINE, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPAP HARMONY S/T, MODEL 1001445 RESPIRONICS, INC. 510(k) NO: K984407(ABBREVIATED) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE DR. SE DECISION MADE: 19-MAY-99 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 RESPIRONICS, INC. 510(k) NO: K990574(TRADITIONAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE DR. SE DECISION MADE: 24-MAY-99 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 RESPIRONICS, INC. 510(k) NO: K991627(SPECIAL) ATTN: BETSY CORTELLONI PHONE NO : 770-429-2894 1255 KENNESTONE CIR. SE DECISION MADE: 17-MAY-99 MARIETTA, GA 30066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE CONTOUR II NASAL MASK RESPIRONICS, INC. 510(k) NO: K991648(SPECIAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE DRIVE SE DECISION MADE: 28-MAY-99 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERI RIVERSTONE RESOURCES SDN. BHD. 510(k) NO: K990963(TRADITIONAL) ATTN: CHU MEE CHONG PHONE NO : 603 636 8077 5, LORONG HELANG HINDIK SE DECISION MADE: 26-MAY-99 KEPONG BARU INDUSTRIAL ESTATE 510(k) STATEMENT KUALA LUMPAR, MALAYSIA 52100 DEVICE: NORMAL SALINE FLUSH SYRINGE ROCAP DIV. OF SABRATEK CORP. 510(k) NO: K984614(TRADITIONAL) ATTN: AVIA TONEY PHONE NO : 407-855-5104 1629 PRIME COURT SE DECISION MADE: 27-MAY-99 BUILDING 100 510(k) STATEMENT ORLANDO, FL 32809 DEVICE: MODIFICATION TO ABUSCREEN ONLINE BARBITURATES ROCHE DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K983698(TRADITIONAL) ATTN: RITA SMITH PHONE NO : 908-253-7545 BRANCHBURG TOWNSHIP SE DECISION MADE: 03-MAY-99 1080 U.S. HIGHWAY 202 510(k) SUMMARY AVAILABLE FROM FDA BRANCHBURG, NJ 08876-3771 DEVICE: ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE MOLECULAR SYSTEMS, INC. 510(k) NO: K974342(TRADITIONAL) ATTN: ALEX WESOLOWSKI PHONE NO : 908-253-7540 1080 U.S. HIGHWAY 202 SE DECISION MADE: 28-MAY-99 SOMERVILLE, NJ 08876-3771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODE ROGER L. GOODMAN, D.D.S., P.C. 510(k) NO: K984270(TRADITIONAL) ATTN: ROGER L GOODMAN PHONE NO : 517-676-5200 200 TEMPLE ST. SE DECISION MADE: 20-MAY-99 MASON, MI 48854-1837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF SAS SERUM/URINE HCG SA SCIENTIFIC, INC. 510(k) NO: K990684(TRADITIONAL) ATTN: JOSH WESSLING PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 10-MAY-99 SAN ANTONIO, TX 78240 510(k) STATEMENT DEVICE: SAS ONE-STEP PREGNANCY SA SCIENTIFIC, INC. 510(k) NO: K990741(TRADITIONAL) ATTN: HARBI A SHADFAN PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 10-MAY-99 SAN ANTONIO, TX 78240 510(k) STATEMENT DEVICE: SAS HCG-CHECK SA SCIENTIFIC, INC. 510(k) NO: K991193(TRADITIONAL) ATTN: J. WESSLING PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 04-MAY-99 SAN ANTONIO, TX 78240 510(k) STATEMENT DEVICE: EASYSAFE RETRACTING NEEDLE SYRINGE SAF-T-MED, INC. 510(k) NO: K991039(TRADITIONAL) ATTN: JAMES ERBS PHONE NO : 847-842-8444 1250 SOUTH GROVE, SUITE 200 SE DECISION MADE: 21-MAY-99 BARRINGTON, IL 60010-5011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50M SAFESKIN CORP. 510(k) NO: K991317(TRADITIONAL) ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010 12671 HIGH BLUFF DR. SE DECISION MADE: 21-MAY-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) SALTER LABORATORIES 510(k) NO: K990678(TRADITIONAL) ATTN: DUANE KAZAL PHONE NO : 805-854-3166 100 WEST SYCAMORE RD. SE DECISION MADE: 07-MAY-99 ARVIN, CA 93203 510(k) STATEMENT DEVICE: LATEX EXAMINATION GLOVES (POWDERED) SAMA KEJURUTERAAN SDN.BHD. 510(k) NO: K984229(TRADITIONAL) ATTN: KUAN TECK PHONE NO : 603 961 5981 TAMAN BUKIT BELIMBING SE DECISION MADE: 17-MAY-99 43300 BALAKONG 510(k) STATEMENT SELANGOR D.E., MALAYSIA 43300 DEVICE: CVS PERSONAL LUBRICANT SAN-MAR LABORATORIES, INC. 510(k) NO: K983216(ABBREVIATED) ATTN: IRWIN SILVERBERG PHONE NO : 914-592-3130 4 WAREHOUSE LANE SE DECISION MADE: 17-MAY-99 ELMSFORD, NY 10523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 SANDHILL SCIENTIFIC, INC. 510(k) NO: K990441(TRADITIONAL) ATTN: LINDA L DIEDERICH PHONE NO : 303-470-7020 8955 SOUTH RIDGELINE BLVD., SE DECISION MADE: 12-MAY-99 UNIT #500 510(k) SUMMARY AVAILABLE FROM FDA HIGHLANDS RANCH, CO 80126 DEVICE: DPD-12PCC SCANDITRONIX MEDICAL AB 510(k) NO: K990734(SPECIAL) ATTN: EVA LARSTEN PHONE NO : 461 818 0700 STALGATAN 14 SE DECISION MADE: 28-MAY-99 UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET SCHNEIDER/NAMIC 510(k) NO: K983039(TRADITIONAL) ATTN: KARIN L SMITH PHONE NO : 518-798-0067 PRUYN'S ISLAND SE DECISION MADE: 07-MAY-99 GLENS FALLS, NY 12801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOLOCK SPINAL SYSTEM SCIENT'X 510(k) NO: K990721(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 27-MAY-99 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRIST BLOOD PRESSURE METER MODEL SE-330 SEIN ELECTRONICS CO., LTD. 510(k) NO: K973078(TRADITIONAL) ATTN: BRENDA M KELLY PHONE NO : 201-529-3111 ONE LETHBRIDGE PLAZA , SE DECISION MADE: 20-MAY-99 SUITE #1 510(k) SUMMARY AVAILABLE FROM FDA MAHWAH, NJ 07430 DEVICE: EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR SELFCARE, INC. 510(k) NO: K991386(TRADITIONAL) ATTN: CAROL ADILETTO PHONE NO : 781-647-3900 200 PROSPECT ST. SE DECISION MADE: 25-MAY-99 WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICT SELFCARE, INC. 510(k) NO: K991466(TRADITIONAL) ATTN: CAROL ADILETTO PHONE NO : 781-647-3900 200 PROSPECT ST. SE DECISION MADE: 25-MAY-99 WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CTS-310(B) SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K984161(TRADITIONAL) ATTN: ROBERT MORTON PHONE NO : 925-210-0715 1106 CHILTERN DRIVE SE DECISION MADE: 05-MAY-99 WALNUT CREEK, CA 94596 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCIUM SCORING SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K990426(TRADITIONAL) ATTN: ALICIA BUSTOS-JUERGENSEN PHONE NO : 732-321-3243 186 WOOD AVE. SOUTH SE DECISION MADE: 12-MAY-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K991661(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 28-MAY-99 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GBACT + KIT SIENCO, INC. 510(k) NO: K984141(SPECIAL) ATTN: BARBARA DEBIASE PHONE NO : 303-420-1148 4892 VAN GORDON ST., UNIT 203 SE DECISION MADE: 28-MAY-99 WHEATRIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "DIGI-SNAP" SNAP LABORATORIES, L.L.C. 510(k) NO: K984169(TRADITIONAL) ATTN: GIL RAVIV PHONE NO : 847-657-8100 3633 WEST LAKE AVE., SUITE 406 SE DECISION MADE: 26-MAY-99 GLENVIEW, IL 60025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM SOFAMOR DANEK 510(k) NO: K991460(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 19-MAY-99 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TENOR SPINAL SYSTEM-PLATES SOFAMOR DANEK USA,INC. 510(k) NO: K991364(SPECIAL) ATTN: BAILEY LIPSCOMB PHONE NO : 901-396-3133 1730 PENNSYLVANIA AVE SE DECISION MADE: 19-MAY-99 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOTOME SONOKINETICS, INC. 510(k) NO: K990572(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893 7 TIFFANY TRAIL SE DECISION MADE: 21-MAY-99 HOPKINTON, MA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANFLEX SOLID COUPLANT MEMBRANE SONOTECH, INC. 510(k) NO: K983691(TRADITIONAL) ATTN: MARGARET J LARSON PHONE NO : 360-671-9121 P.O. BOX 2189 SE DECISION MADE: 05-MAY-99 BELLINGHAM, WA 98227 510(k) STATEMENT DEVICE: 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR SORENSON MEDICAL INC. 510(k) NO: K991363(SPECIAL) ATTN: R. DOUGLAS JACOB PHONE NO : 801-352-1888 1375 WEST 8040 SOUTH SE DECISION MADE: 13-MAY-99 WEST JORDAN, UT 84088-8320 510(k) STATEMENT DEVICE: CONSEAL F SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K990650(TRADITIONAL) ATTN: SAMANTHA J CHEETHAM PHONE NO : 415-975-8060 246 FIRST ST., SUITE 204 SE DECISION MADE: 14-MAY-99 SAN FRANCISCO, CA 94105 510(k) STATEMENT DEVICE: SURGEON'S GLOVES SRI ANUSHAM RUBBER INDUSTRIES PVT.510(k) NO: K984395(TRADITIONAL) ATTN: N. PARAMASIVAN PHONE NO : 914 652 33091 PIONEER MANIKANDAN BLDG. SE DECISION MADE: 21-MAY-99 VADASERY, NAGERCOIL, TN, INDIA 629510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G STERILOGIC WASTE SYSTEMS, INC. 510(k) NO: K991612(TRADITIONAL) ATTN: CALVIN A ODHNER PHONE NO : 610-756-3003 9948 KISTLER VALLEY ROAD SE DECISION MADE: 28-MAY-99 SUITE 102, P.O. BOX 84 510(k) SUMMARY AVAILABLE FROM FDA KEMPTON, PA 19529 DEVICE: STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED P STERNGOLD 510(k) NO: K991436(SPECIAL) ATTN: GORDON NELSON PHONE NO : 508-226-5660 23 FRANK MOSSBERG DR. SE DECISION MADE: 07-MAY-99 ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE VAULT STIK STOPPERS INC. 510(k) NO: K990936(TRADITIONAL) ATTN: DARRYL CRAWFORD PHONE NO : 800-300-1989 6 HAYDEN BRIDGE WAY SE DECISION MADE: 18-MAY-99 SPRINGFIELD, OR 97477 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITI DENTAL IMPLANT SYSTEM STRAUMANN USA 510(k) NO: K984104(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 RESERVOIR PLACE, SE DECISION MADE: 13-MAY-99 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02451 DEVICE: STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM STRYKER INSTRUMENTS 510(k) NO: K991703(SPECIAL) ATTN: NICOLE PETTY PHONE NO : 616-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 27-MAY-99 KALAMAZOO, MI 49001 510(k) STATEMENT DEVICE: SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES SUPERMAX SDN BHD 510(k) NO: K991415(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 657 2328 LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 26-MAY-99 BUKIT RAHMAN PUTRA 510(k) STATEMENT SUNGAI PELONG, SELANGOR, MALAYSIA 47500 DEVICE: SURGISORB SUTURES LTD. 510(k) NO: K990432(TRADITIONAL) ATTN: ELEANOR JONES PHONE NO : 019 788 23664 VAUXHALL IND. ESTATE SE DECISION MADE: 27-MAY-99 RUABON RD. 510(k) STATEMENT CLWYD, UNITED KINGDOM LL14 6HA DEVICE: QUANTEC-E ENDO SYSTEM SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K990739(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 26-MAY-99 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMB SYNERGETICS, INC. 510(k) NO: K990568(TRADITIONAL) ATTN: KURT W GAMPP PHONE NO : 314-939-5100 88 HUBBLE DR. SE DECISION MADE: 14-MAY-99 ST. CHARLES, MO 63304-8694 510(k) STATEMENT DEVICE: TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES TA CHIA RUBBER IND. CORP. 510(k) NO: K990575(TRADITIONAL) ATTN: CHIN-MING YANG PHONE NO : 886 468 63359 903 CHUNG SHAN RD., SEC. 2 SE DECISION MADE: 04-MAY-99 TA CHIA, TAICHUNG, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOV TA CHIA RUBBER IND. CORP. 510(k) NO: K990577(TRADITIONAL) ATTN: CHIN-MING YANG PHONE NO : 886 468 63359 903 CHUNG SHAN RD., SEC. 2 SE DECISION MADE: 04-MAY-99 TA CHIA, TAICHUNG, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: ELECTRODE NEEDLES TECHNOMED EUROPE 510(k) NO: K990015(TRADITIONAL) ATTN: HARRY KNUTH PHONE NO : 31 464 370371 STATIONSTRAAT 122 SE DECISION MADE: 27-MAY-99 P.O. BOX 239 510(k) SUMMARY AVAILABLE FROM FDA 6191 BG BEEK, NETHERLANDS 6191 BG DEVICE: SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE TERANG NUSA SDN BHD 510(k) NO: K990488(TRADITIONAL) ATTN: CHIN GUAN LOW PHONE NO : 609 773 5133 LOT E4(4), JALAN 8 SE DECISION MADE: 28-MAY-99 PENGKALAN CHEPA II FTZ 510(k) SUMMARY AVAILABLE FROM FDA KOTA BHARU, KELANTAN, MALAYSIA 16100 DEVICE: NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE TERANG NUSA SDN BHD 510(k) NO: K990840(TRADITIONAL) ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133 1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 17-MAY-99 INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA KOTA BHARU, KELANTAN, MALAYSIA 16100 DEVICE: NUGARD NITRIL NITRILE EXAMINATION GLOVE TERANG NUSA SDN BHD 510(k) NO: K990841(TRADITIONAL) ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133 1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 17-MAY-99 INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA KOTA BHARU, KELANTAN, MALAYSIA 16100 DEVICE: ETB TROCAR SYSTEM THE ALTOMEC CORP. 510(k) NO: K990894(TRADITIONAL) ATTN: JIM CHITTY PHONE NO : 626-960-3449 400 CRENSHAW BLVD., SUITE 109 SE DECISION MADE: 19-MAY-99 TORRANCE, CA 90503 510(k) STATEMENT DEVICE: NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR THE MAGSTIM COMPANY LTD. 510(k) NO: K991583(SPECIAL) ATTN: REZA JALINOUS PHONE NO : 888-624-7846 730 FIFTH AVE, 9TH FLOOR SE DECISION MADE: 19-MAY-99 NEW YORK, NY 10019 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TTCGHI-T AND TTCTN3-T-T TINNITUS TREATMENT CENTERS, INC. 510(k) NO: K982451(TRADITIONAL) ATTN: DAVID W HOLMES PHONE NO : 800-871-4327 8215 WESTCHESTER, SUITE 150 SE DECISION MADE: 07-MAY-99 DALLAS, TX 75225 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES TOP GLOVE SDN. BHD. 510(k) NO: K990690(TRADITIONAL) ATTN: LIM WEE CHAI PHONE NO : 603 392 19921905 41050 KLANG,SELANGOR SE DECISION MADE: 20-MAY-99 DARUL EHSAN, MALAYSIA 510(k) STATEMENT DEVICE: EXCELART TOSHIBA AMERICA MRI, INC. 510(k) NO: K990620(TRADITIONAL) ATTN: HSU CHANG PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 14-MAY-99 SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTRA LARGE BODY COIL FOR OPART (MRT-600) TOSHIBA AMERICA MRI, INC. 510(k) NO: K991057(TRADITIONAL) ATTN: KEN NEHMER PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 20-MAY-99 SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIA-PACK FT3 ASSAY TOSOH MEDICS, INC. 510(k) NO: K991252(TRADITIONAL) ATTN: LOIS NAKAYAMA PHONE NO : 650-615-4970 347 OYSTER POINT BLVD., SE DECISION MADE: 11-MAY-99 SUITE 201 510(k) STATEMENT SOUTH SAN FRANCISCO, CA 94080 DEVICE: POWDER FREE LATEX EXAMINATION GLOVES TOWER RUBBER INDUSTRIES SDN. BHD. 510(k) NO: K990686(TRADITIONAL) ATTN: S. VICKNESWARAN PHONE NO : 603 376 1568 LOT 18, JALAN LINGKARAN SULTAN SE DECISION MADE: 04-MAY-99 HISHAMUDDIN, KAW. PERUSAHAAN 510(k) STATEMENT SELAT KLANG UTARA, PORT KLANG, MALAYSIA 42000 DEVICE: UROMED BRACHYTHERAPHY IODINE-125 SOURCES UROMED CORP. 510(k) NO: K982226(TRADITIONAL) ATTN: FREDERICK TOBIA PHONE NO : 781-433-0033 64 A ST. SE DECISION MADE: 13-MAY-99 NEEDHAM, MA 02194 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1000 PRESSURE INFUSION SIGMACON 1000 VALLEY WEST, INC. 510(k) NO: K990447(TRADITIONAL) ATTN: C. KENNETH FRENCH PHONE NO : 254-435-2306 HWY. 6 NORTH SE DECISION MADE: 12-MAY-99 MERIDIAN, TX 76665 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTA STEREOSCOPE SYSTEM VISTA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K990635(TRADITIONAL) ATTN: VICKI S ANASTASI PHONE NO : 508-366-3668 134 FLANDERS RD. SE DECISION MADE: 19-MAY-99 WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISTAKON, JOHNSON & JOHNSON VISION510(k) NO: K991134(TRADITIONAL) ATTN: MARTINE D MARTINO PHONE NO : 904-443-1808 4500 SALISBURY ROAD SE DECISION MADE: 06-MAY-99 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32216 DEVICE: ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 VITAL IMAGES, INC. 510(k) NO: K990442(TRADITIONAL) ATTN: ROBERT C SAMEC PHONE NO : 612-915-8001 3100 WEST LAKE ST. SE DECISION MADE: 11-MAY-99 MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) WALLACH SURGICAL DEVICES, INC. 510(k) NO: K983840(TRADITIONAL) ATTN: MICHAEL MALIS PHONE NO : 203-799-2000 235 EDISON RD. SE DECISION MADE: 20-MAY-99 ORANGE, CT 06477 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ IMF SCREW WALTER LORENZ SURGICAL, INC. 510(k) NO: K983728(TRADITIONAL) ATTN: DIANA PRESTON PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 13-MAY-99 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER WASHINGTON REGULATORY SERVICES 510(k) NO: K983604(TRADITIONAL) ATTN: RANDOLPH L COOKE PHONE NO : 609-466-0510 23 WELISEWITZ ROAD SE DECISION MADE: 27-MAY-99 RINGOES, NJ 08551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESGLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL H WESLEY-JESSEN 510(k) NO: K991550(TRADITIONAL) ATTN: JOSEPH FOOS PHONE NO : 847-294-3306 333 EAST HOWARD AVE. SE DECISION MADE: 14-MAY-99 DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST ZEUS SCIENTIFIC, INC. 510(k) NO: K983805(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 P.O. BOX 38 SE DECISION MADE: 26-MAY-99 RARITAN, NJ 08869 510(k) STATEMENT DEVICE: THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYS ZEUS SCIENTIFIC, INC. 510(k) NO: K984120(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 26-MAY-99 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SY ZEUS SCIENTIFIC, INC. 510(k) NO: K984135(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 26-MAY-99 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: GAS PLASMA STERILIZATION ZIMMER, INC. 510(k) NO: K972774(TRADITIONAL) ATTN: RALPH H LARSEN PHONE NO : 219-372-4129 P.O. BOX 708 SE DECISION MADE: 05-MAY-99 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW ZYMED CORP. 510(k) NO: K990093(TRADITIONAL) ATTN: DUDLEY HARRIS PHONE NO : 800-235-5941 20 NORTH AVIADOR ST. SE DECISION MADE: 11-MAY-99 CAMARILLO, CA 93010 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 248 TOTAL WITH SUMMARIES 162 TOTAL WITH STATEMENTS 86
-
-