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Medical Devices
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July 1999 510(k) Clearances
DEVICE: EMS SWISS ORTHOCLAST (EMS SA) ELECTRO MEDICAL SYSTEMS 510(k) NO: K991588(TRADITIONAL) ATTN: SHEILA HAMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 21-JUL-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMS SURFACE MOUNT SCALER (EMS SA) ELECTRO MEDICAL SYSTEMS 510(k) NO: K991874(TRADITIONAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 30-JUL-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FERTILIZATION MEDIA-HTF INTL., INC. 510(k) NO: K991173(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453 170 FORT PATH RD., UNIT 14 SE DECISION MADE: 19-JUL-99 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 A.P. TOTAL CARE, INC. 510(k) NO: K991870(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 30-JUL-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: AWARE PAD AAC CONSULTING GROUP, INC. 510(k) NO: K991469(TRADITIONAL) ATTN: EDUARDO MARCH PHONE NO : 301-986-4440 7475 WISCONSIN AVE., SUITE 850 SE DECISION MADE: 20-JUL-99 BETHESDA, MD 20814 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), ABBOTT LABORATORIES, INC. 510(k) NO: K991605(TRADITIONAL) ATTN: MICHELLE B ROEDING PHONE NO : 408-567-3781 5440 PATRICK HENRY DR. SE DECISION MADE: 09-JUL-99 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY, INC. 510(k) NO: K984563(TRADITIONAL) ATTN: LUANNE TERMEER PHONE NO : 408-522-3740 570 DEL REY AVE. SE DECISION MADE: 14-JUL-99 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGE 2.5 ADAC LABORATORIES 510(k) NO: K991607(TRADITIONAL) ATTN: DENNIS W HENKELMAN PHONE NO : 408-468-3989 540 ALDER DR. SE DECISION MADE: 26-JUL-99 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR ADAM SPENCE CORP. 510(k) NO: K983940(TRADITIONAL) ATTN: CAROL ROSENBLOOM PHONE NO : 732-681-7070 1746 RT. 34 SE DECISION MADE: 15-JUL-99 WALL, NJ 07719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS ADVENTURE IN COLORS, INC. 510(k) NO: K992054(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 07-JUL-99 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE AESCULAP-MEDITEC NORTH AMERICA 510(k) NO: K991285(TRADITIONAL) ATTN: WILLIAM KELLEY PHONE NO : 949-660-2770 2525 MCGAW AVE. SE DECISION MADE: 12-JUL-99 IRVINE, CA 92623-9791 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K991546(TRADITIONAL) ATTN: JOAN ZACHAROPOULOS PHONE NO : 914-268-0101 360 NORTH ROUTE 9W SE DECISION MADE: 30-JUL-99 CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991992(SPECIAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKEGAN RD., K SE DECISION MADE: 13-JUL-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "RAPIDONE" - MARIJUANA TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K990818(TRADITIONAL) ATTN: JOHN B DUBECK PHONE NO : 202-434-4125 1001 G STREET, NW SE DECISION MADE: 07-JUL-99 SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20001 DEVICE: "RAPIDONE" - OPIATES TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K990820(TRADITIONAL) ATTN: JOHN B DUBECK PHONE NO : 202-434-4125 1001 G STREET, NW SE DECISION MADE: 15-JUL-99 SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20001 DEVICE: "RAPIDONE - COCAINE TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K990822(TRADITIONAL) ATTN: JOHN B DUBECK PHONE NO : 202-434-4125 1001 G STREET, NW SE DECISION MADE: 15-JUL-99 SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20001 DEVICE: DBSET MULTIDRUG SCREEN TEST KIT AMERITEK, INC. 510(k) NO: K990681(TRADITIONAL) ATTN: K. C. YEE PHONE NO : 206-527-5086 7030 35TH AVE., N.E. SE DECISION MADE: 15-JUL-99 SEATTLE, WA 98115 510(k) STATEMENT DEVICE: WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION ANALOGIC CORP. 510(k) NO: K991626(SPECIAL) ATTN: GARET VAN GENNEP PHONE NO : 978-977-3000 8 CENTENNIAL DR. SE DECISION MADE: 02-JUL-99 PEABODY, MA 01960 510(k) STATEMENT DEVICE: LIFESTYLES XTRA PLEASURE ANSELL, INC. 510(k) NO: K983518(TRADITIONAL) ATTN: LON MCILVAIN PHONE NO : 334-794-4231 1500 INDUSTRIAL RD. SE DECISION MADE: 06-JUL-99 DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANSELL CONDOMS ANSELL, INC. 510(k) NO: K984392(TRADITIONAL) ATTN: LON MCLLVAIN PHONE NO : 334-794-4231 1500 INDUSTRIAL ROAD SE DECISION MADE: 21-JUL-99 DOTHAN, AL 36302 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLIED BIOTECH SURESTEP DRUG SCREEN MULTI TEST (2) APPLIED BIOTECH, INC. 510(k) NO: K991816(TRADITIONAL) ATTN: ROGER KOTTER PHONE NO : 619-587-6771 10237 FLANDERS CT. SE DECISION MADE: 28-JUL-99 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: AVE GL-1 GUIDING CATHETER ARTERIAL VASCULAR ENGINEERING MASS510(k) NO: K984482(TRADITIONAL) ATTN: NORMA J LEMAY PHONE NO : 978-667-2511 129 CONCORD ROAD SE DECISION MADE: 30-JUL-99 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER ARTERIAL VASCULAR ENGINEERING, INC510(k) NO: K984627(TRADITIONAL) ATTN: DEBORAH L HERRINGTON PHONE NO : 978-671-3361 129 CONCORD ROAD SE DECISION MADE: 27-JUL-99 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X ASAHI MEDICAL CO., LTD. 510(k) NO: K991512(TRADITIONAL) ATTN: DAVID L WEST PHONE NO : 301-548-0504 15825 SHADY GROVE ROAD, SE DECISION MADE: 29-JUL-99 SUITE 90 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM ASTRA TECH, INC. 510(k) NO: K990304(TRADITIONAL) ATTN: NIKLAS LIDSKOG PHONE NO : 781-861-7707 430 BEDFORD ST. SE DECISION MADE: 15-JUL-99 LEXINGTON, MA 02173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASOUND SCANNER, MODEL TYPE 2101 B & K MEDICAL A/S 510(k) NO: K991937(SPECIAL) ATTN: VILLY BRAENDER PHONE NO : 011 454 5970100 SANDTOFTEN 9 SE DECISION MADE: 30-JUL-99 GENTOFTE, DENMARK DK-2820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUER ACCESS INJECTION SITE BAXTER HEALTHCARE CORP. 510(k) NO: K984060(TRADITIONAL) ATTN: MARY ELLEN SNYDER PHONE NO : 847-270-4644 CLINTEC NUTRITION CO. SE DECISION MADE: 26-JUL-99 ROUTE 120 AND WILSON ROAD 510(k) SUMMARY AVAILABLE FROM FDA ROUND LAKE, IL 60073 DEVICE: RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DI BAXTER RESEARCH MEDICAL, INC. 510(k) NO: K991170(TRADITIONAL) ATTN: JOHN W SMITH PHONE NO : 801-565-6213 6864 SOUTH 300 WEST SE DECISION MADE: 02-JUL-99 MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD BAYER CORP. 510(k) NO: K990649(TRADITIONAL) ATTN: GEORGE M TANCOS PHONE NO : 219-262-6928 1884 MILES AVE. SE DECISION MADE: 09-JUL-99 ELKHART, IN 46515-2004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP. 510(k) NO: K991817(TRADITIONAL) ATTN: GABRIEL J MURACA JR. PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 22-JUL-99 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL BECTON DICKINSON VACUTAINER SYSTEM510(k) NO: K991702(TRADITIONAL) ATTN: ANDREA HRONCICCH PHONE NO : 201-847-6173 ONE BECTON DR SE DECISION MADE: 28-JUL-99 FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHROMOPHARE D 530 LDR SURGICAL LIGHT BERCHTOLD GMBH & CO. 510(k) NO: K990656(TRADITIONAL) ATTN: WOLFRAM K HILL PHONE NO : 004 974 61181370 LUDWIGSTALER STR. 25 SE DECISION MADE: 20-JUL-99 TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 BIOCHECK, INC. 510(k) NO: K991741(TRADITIONAL) ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646 9418 LASAINE AVE SE DECISION MADE: 22-JUL-99 NORTHRIDGE, CA 91325 510(k) STATEMENT DEVICE: SCARAID SILICONE GEL SHEETING BIODERMIS CORP. 510(k) NO: K992146(TRADITIONAL) ATTN: JEFF S SCHLEUNING PHONE NO : 800-322-3729 3078 EAST SUNSET RD. SUITE #1 SE DECISION MADE: 30-JUL-99 LAS VEGAS, NV 89120 510(k) STATEMENT DEVICE: AGC V2 REVISION KNEE SYSTEM BIOMET, INC. 510(k) NO: K984054(TRADITIONAL) ATTN: PATRICIA BERES PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 30-JUL-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: ZIRCONIA 22.22MM CERAMIC MODULAR HEADS BIOMET, INC. 510(k) NO: K991708(ABBREVIATED) ATTN: DALENE HUFZIGER BINKLEY PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 30-JUL-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: LACTOSORB HAND SYSTEM BIOMET, INC. 510(k) NO: K991763(TRADITIONAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 30-JUL-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: TITANIUM LOW PROFILE SCREWS BIOMET, INC. 510(k) NO: K991807(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 08-JUL-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM BIOMET, INC. 510(k) NO: K992058(SPECIAL) ATTN: MARY L VERSTYNEN PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 01-JUL-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: PERFORMANCE KNEE SYSTEM BIOMET, INC. 510(k) NO: K992167(SPECIAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 28-JUL-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: BIOTHANE PATIENT RESTRAINT BIOPLASTICS 510(k) NO: K991591(TRADITIONAL) ATTN: CLAIRE BORON PHONE NO : 440-327-0485 34655 MILLS ROAD SE DECISION MADE: 29-JUL-99 N. RIDGEVILLE, OH 44039 510(k) STATEMENT DEVICE: BIOSACA SYSTEM, MODEL 800 BIOSYS AB (PUBL) 510(k) NO: K991446(TRADITIONAL) ATTN: JANE B CAMPBELL PHONE NO : 914-469-4289 485 LAROE ROAD SE DECISION MADE: 23-JUL-99 CHESTER, NY 10918 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CMV BRITE TURBO KIT BIOTEST DIAGNOSTICS CORP. 510(k) NO: K991650(SPECIAL) ATTN: PATRICIA E BONNESS PHONE NO : 609-397-8511 66 FORD RD., SUITE 131 SE DECISION MADE: 12-JUL-99 DENVILLE, NJ 07834 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 BIOTRONIK, INC. 510(k) NO: K991169(TRADITIONAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 01-JUL-99 LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY BOSTON SCIENTIFIC CORP. 510(k) NO: K982326(TRADITIONAL) ATTN: LAURA MONDANO PHONE NO : 508-650-8173 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 13-JUL-99 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LC PIT & FISSURE SEALANT BOSWORTH CO. 510(k) NO: K991902(TRADITIONAL) ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400 7227 NORTH HAMLIN AVENUE SE DECISION MADE: 26-JUL-99 SKOKIE, IL 60076-3999 510(k) STATEMENT DEVICE: EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) BRAINLAB USA, INC. 510(k) NO: K983660(TRADITIONAL) ATTN: ERIC LINDQUIST PHONE NO : 650-494-7240 3100 HANSEN WAY SE DECISION MADE: 14-JUL-99 BUILDING 4A, MAILSTOP E233 510(k) STATEMENT PALO ALTO, CA 94304 DEVICE: STAINLESS STEEL SOFT SUTURE WIRE BREGMA INTERNATIONAL TRADING COMPA510(k) NO: K990355(TRADITIONAL) ATTN: ASSEM HEDAYAT PHONE NO : 306 934 8270 214-111 RESEARCH DRIVE SE DECISION MADE: 08-JUL-99 SASKATOON, SASKATCHEWAN, CANADA S7510(k) STATEMENT DEVICE: BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) BRIGHTSWAY HOLDINGS SDN BHD 510(k) NO: K992020(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 26-JUL-99 BATU BELAH 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) BRIGHTSWAY HOLDINGS SDN BHD 510(k) NO: K992021(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 23-JUL-99 BATU BELAH 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K991939(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 01-JUL-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K991940(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 12-JUL-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: SUMMER'S EVE LUBRICATING JELLY C.B. FLEET CO., INC. 510(k) NO: K990597(TRADITIONAL) ATTN: PETER S REICHERTZ PHONE NO : 202-857-6378 1050 CONNECTICUT AVENUE N.W. SE DECISION MADE: 19-JUL-99 WASHINGTON, DC 20036 510(k) STATEMENT DEVICE: PRO-GLASS CAD CAM VENTURES 510(k) NO: K991844(TRADITIONAL) ATTN: RON FISHELL PHONE NO : 888-655-5010 3301 COFLANS RD SE DECISION MADE: 21-JUL-99 SUITE 104 510(k) STATEMENT IRVING, TX 75061 DEVICE: ACIER SUTURES CARDIO THORACIC SYSTEMS 510(k) NO: K991073(TRADITIONAL) ATTN: MICHAEL J BILLIG PHONE NO : 408-342-1700 10600 N. TANTAU AVENUE SE DECISION MADE: 30-JUL-99 CUPERTINO, CA 95014-0739 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOYAGER QUAD CANNULA CARDIOTHORACIC SYSTEMS, INC. 510(k) NO: K983270(TRADITIONAL) ATTN: MIKE BILLIG PHONE NO : 408-342-1700 10600 NORTH TANTAU AVE. SE DECISION MADE: 28-JUL-99 CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE PT CARESIDE, INC. 510(k) NO: K991065(TRADITIONAL) ATTN: NENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 26-JUL-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOCUMENT THYROID CAL*VER CASCO-NERL DIAGNOSTICS CORPORATION510(k) NO: K992034(TRADITIONAL) ATTN: KAREN HICKEY PHONE NO : 207-878-7550 500 RIVERSIDE INDUSTRIAL PKWY. SE DECISION MADE: 23-JUL-99 PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) CHROMAVISION MEDICAL SYSTEMS, INC.510(k) NO: K984188(TRADITIONAL) ATTN: BERTRAM J HUDSON PHONE NO : 972-355-9700 3535 FIREWHEEL DRIVE SE DECISION MADE: 28-JUL-99 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA FLOWER MOUND, TX 75028-2628 DEVICE: SOLO-CARE BRAND MULTI-PURPOSE SOLUTION CIBA VISION CORP. 510(k) NO: K991403(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 770-418-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 16-JUL-99 DULUTH, GA 30155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTOOLS CONCEPTION TECHNOLOGY INC. 510(k) NO: K991104(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 19-JUL-99 IRVINE, CA 92606 510(k) STATEMENT DEVICE: ENHANCE-S PLUS CONCEPTION TECHNOLOGY INC. 510(k) NO: K991322(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 26-JUL-99 IRVINE, CA 92606 510(k) STATEMENT DEVICE: QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT CONMED CORP. 510(k) NO: K992186(TRADITIONAL) ATTN: IRA D DUESLER, JR PHONE NO : 315-797-8375 310 BROAD ST. SE DECISION MADE: 30-JUL-99 UTICA, NY 13501-1203 510(k) STATEMENT DEVICE: REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE CONSOLIDATED TECHNOLOGIES INC. 510(k) NO: K992151(TRADITIONAL) ATTN: E. KAY ROBINSON PHONE NO : 512-445-5100 2170 WOODARD STREET SE DECISION MADE: 14-JUL-99 STE. 100 510(k) STATEMENT AUSTIN, TX 78744-1832 DEVICE: "STRETTA" INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION CONWAY STUART MEDICAL, INC. 510(k) NO: K991291(TRADITIONAL) ATTN: DAVID A TUCKER PHONE NO : 408-733-9910 735 PALOMAR ST. SE DECISION MADE: 14-JUL-99 SUNNYVALE, CA 94086 510(k) STATEMENT DEVICE: WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N COOPERSURGICAL, INC. 510(k) NO: K990348(TRADITIONAL) ATTN: DEBRA A PEKAR PHONE NO : 203-929-6321 15 FOREST PARKWAY SE DECISION MADE: 26-JUL-99 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE S COOPERSURGICAL, INC. 510(k) NO: K990349(TRADITIONAL) ATTN: DEBRA A PARKER PHONE NO : 203-929-6321 15 FOREST PARKWAY SE DECISION MADE: 26-JUL-99 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MOD COOPERSURGICAL, INC. 510(k) NO: K990350(TRADITIONAL) ATTN: DEBRA A PEKAR PHONE NO : 203-929-6321 15 FOREST PARKWAY SE DECISION MADE: 26-JUL-99 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILON CORRECT-TOUCH CT INTL. 510(k) NO: K984512(TRADITIONAL) ATTN: MIKE KYLE PHONE NO : 805-544-5572 4349 SANTA FE RD SE DECISION MADE: 12-JUL-99 SAN LUIS OBISPO, CA 93401 510(k) STATEMENT DEVICE: CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER CYNOSURE, INC. 510(k) NO: K992084(SPECIAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 12-JUL-99 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DADE BEHRING BFTII DADE BEHRING, INC. 510(k) NO: K984501(TRADITIONAL) ATTN: CAROLYN K GEORGE PHONE NO : 781-826-2073 P.O. BOX 6101 SE DECISION MADE: 28-JUL-99 GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: OPUS TROPONIN I CALIBRATOR DADE BEHRING, INC. 510(k) NO: K991176(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 PO BOX 6101 SE DECISION MADE: 01-JUL-99 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPUS TROPONIN I (CTN) TEST MODULES DADE BEHRING, INC. 510(k) NO: K991177(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 PO BOX 6101 SE DECISION MADE: 01-JUL-99 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N PROTEIN STANDARD UY DADE BEHRING, INC. 510(k) NO: K991705(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 781-826-2073 GLASGOW SITE SE DECISION MADE: 15-JUL-99 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714 DEVICE: N LATEX IGE MONO REAGENT DADE BEHRING, INC. 510(k) NO: K991787(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW SITE SE DECISION MADE: 07-JUL-99 P.O. BOX 6101 510(k) SUMMARY NEWARK, DE 19714 DEVICE: SNORE-AID PLUS DENTAL IMAGINEERS & ASSOCIATES 510(k) NO: K991449(TRADITIONAL) ATTN: WILLIAM BELFER PHONE NO : 732-493-4747 804 WEST PARK AVE. SE DECISION MADE: 22-JUL-99 OCEAN, NJ 07712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTEC LD 15 DIODE LASER DENTEK LASERSYSTEMS PRODUKTIONS GE510(k) NO: K990680(TRADITIONAL) ATTN: DI WOLFGANG NINAUS PHONE NO : 433 162 65204 GROTTENHOFSTRASSE 3 SE DECISION MADE: 30-JUL-99 GRAZ, AUSTRIA A - 8053 510(k) STATEMENT DEVICE: GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL DEPUY ORTHOPAEDICS, INC. 510(k) NO: K992065(SPECIAL) ATTN: JANET JOHNSON PHONE NO : 219-372-7484 700 ORTHOPAEDIC DR. SE DECISION MADE: 12-JUL-99 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY ROCKWOOD CLAVICLE PIN DEPUY, INC. 510(k) NO: K991649(TRADITIONAL) ATTN: SALLY FOUST PHONE NO : 219-372-7455 700 ORTHOPAEDIC DR. SE DECISION MADE: 14-JUL-99 P.O. BOX 988 510(k) SUMMARY WARSAW, IN 46581-0988 DEVICE: DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING DERMAPHYLYX, INC. 510(k) NO: K991608(TRADITIONAL) ATTN: ANDREW M REED PHONE NO : 303-431-6796 12106, WEST 75TH LANE SE DECISION MADE: 20-JUL-99 ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING DERMAPHYLYX, INC. 510(k) NO: K991609(TRADITIONAL) ATTN: ANDREW M REED PHONE NO : 303-431-6796 12106, WEST 75TH LANE SE DECISION MADE: 20-JUL-99 ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF DEROYAL INDUSTRIES, INC. 510(k) NO: K991525(TRADITIONAL) ATTN: LOIS MARSH PHONE NO : 423-362-6217 200 DEBUSK LANE SE DECISION MADE: 20-JUL-99 POWELL, TN 37849 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE DHD HEALTHCARE CORP. 510(k) NO: K991300(TRADITIONAL) ATTN: LARRY WEINSTEIN PHONE NO : 800-847-8000 ONE MADISON ST. SE DECISION MADE: 12-JUL-99 WAMPSVILLE, NY 13163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K983203(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 12-JUL-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE TURBO INTACT PTH, MODEL LSKPTZ DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K992105(SPECIAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 06-JUL-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATR DIAMETRICS MEDICAL, LTD. 510(k) NO: K980380(TRADITIONAL) ATTN: J L WALTERS PHONE NO : 494 446 651 SHORT STREET SE DECISION MADE: 14-JUL-99 HIGH WYCOMBE, BUCKS, UNITED KINGDO510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETI-EA-G ASSAY DIASORIN INC. 510(k) NO: K992191(TRADITIONAL) ATTN: JUDITH J SMITH PHONE NO : 9175 GUIFORD ROAD SE DECISION MADE: 12-JUL-99 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAREX DRAIN SPONGE DYNAREX CORP. 510(k) NO: K991694(TRADITIONAL) ATTN: JOHN G MOULDEN PHONE NO : 914-279-9600 ONE INTERNATIONAL BLVD. SE DECISION MADE: 15-JUL-99 BREWSTER, NY 10509 510(k) STATEMENT DEVICE: DYNAREX NON-WOVEN SPONGE DYNAREX CORP. 510(k) NO: K991695(TRADITIONAL) ATTN: JOHN G MOULDEN PHONE NO : 914-279-9600 ONE INTERNATIONAL BLVD. SE DECISION MADE: 15-JUL-99 BREWSTER, NY 10509 510(k) STATEMENT DEVICE: ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATO ELAN HOLDINGS, INC. 510(k) NO: K991789(TRADITIONAL) ATTN: WYNN STOCKING PHONE NO : 714-871-8360 231 NORTH PUENTE ST. SE DECISION MADE: 09-JUL-99 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWISS LITHOCLAST MULTIPURPOSE PROBE ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K992251(SPECIAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 27-JUL-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEKTA STEREOTACTIC GUIDE ELEKTA INSTRUMENT AB 510(k) NO: K991636(TRADITIONAL) ATTN: SVERKER GLANS PHONE NO : 011 468 58725400 21911 ERIE LANE SE DECISION MADE: 20-JUL-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RES ENGINEERED MEDICAL SYSTEMS 510(k) NO: K991953(TRADITIONAL) ATTN: BONNIE HOLLY PHONE NO : 371-246-5500 2055 EXECUTIVE DR. SE DECISION MADE: 01-JUL-99 INDIANAPOLIS, IN 46241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RES ENGINEERED MEDICAL SYSTEMS 510(k) NO: K991955(TRADITIONAL) ATTN: BONNIE HOLLY PHONE NO : 371-246-5500 2055 EXECUTIVE DR. SE DECISION MADE: 06-JUL-99 INDIANAPOLIS, IN 46241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENTAMIX 2 ESPE DENTAL AG 510(k) NO: K991913(TRADITIONAL) ATTN: A. PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 26-JUL-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMAL ANGEL ESTILL MEDICAL TECHNOLOGIES, INC. 510(k) NO: K984640(TRADITIONAL) ATTN: THOMAS KISTNER PHONE NO : 972-818-1872 17440 N. DALLAS PARKWAY SE DECISION MADE: 01-JUL-99 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA DALLAS, TX 75287 DEVICE: XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 EXCEL TECH. LTD. 510(k) NO: K991900(TRADITIONAL) ATTN: MARK T ZAJAC PHONE NO : 905 829 5300 X297 2892 PORTLAND DR. SE DECISION MADE: 12-JUL-99 OAKVILLE, ONTARIO, CANADA L6H 5W8510(k) STATEMENT DEVICE: FCI CRAWFORD PROBE INTUBATION SETS FCI OPHTHALMICS, INC. 510(k) NO: K991238(TRADITIONAL) ATTN: ANNE BOHSACK PHONE NO : 781-837-4416 P.O. BOX 465 SE DECISION MADE: 08-JUL-99 76 PROSPECT ST. 510(k) STATEMENT MARSHFIELD HILLS, MA 02051 DEVICE: NASO-LARYNGO-PHARYNGOSCOPE FIBER IMAGING TECHNOLOGIES, INC. 510(k) NO: K991560(TRADITIONAL) ATTN: JOSEPH RESS PHONE NO : 617-965-7714 45 PONTIAC ROAD SE DECISION MADE: 13-JUL-99 NEWTON, MA 02468 510(k) STATEMENT DEVICE: DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 FISMA, INC. 510(k) NO: K991464(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-972-0500 3959 WEST 1820 SOUTH SE DECISION MADE: 20-JUL-99 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K991520(TRADITIONAL) ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 TWO LEDGEMONT CENTER SE DECISION MADE: 30-JUL-99 95 HAYDEN AVE. 510(k) STATEMENT LEXINGTON, MA 02420 DEVICE: CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, GALIL MEDICAL LTD. 510(k) NO: K991272(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600 555 THIRTEEN ST. SE DECISION MADE: 12-JUL-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 GALIL MEDICAL LTD. 510(k) NO: K991517(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEEN ST. SE DECISION MADE: 27-JUL-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACRON MC MODIFICATION GC AMERICA, INC. 510(k) NO: K991774(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-597-0900 3737 WEST 127TH STREET SE DECISION MADE: 09-JUL-99 ALSIP, IL 60803 510(k) STATEMENT DEVICE: SOLAR 9500 INFORMATION MONITOR GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K990068(TRADITIONAL) ATTN: KAREN WEBB PHONE NO : 414-362-3329 8200 WEST TOWER AVE. SE DECISION MADE: 14-JUL-99 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS, INC. 510(k) NO: K992208(TRADITIONAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 12-JUL-99 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEBAUER'S CHLORIDE FINE NOZZE GEBAUER CO. 510(k) NO: K991514(TRADITIONAL) ATTN: DENISE E SPELLMAN PHONE NO : 216-271-5252 9410 ST. CATHERINE AVE. SE DECISION MADE: 16-JUL-99 CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMEX GENDEX-DEL MEDICAL IMAGING CORP. 510(k) NO: K992037(SPECIAL) ATTN: JEFFREY N MOELLER PHONE NO : 847-288-7000 11550 WEST KING ST. SE DECISION MADE: 30-JUL-99 FRANKLIN PARK, IL 60131 510(k) STATEMENT DEVICE: SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 GENICON, LC 510(k) NO: K991382(TRADITIONAL) ATTN: GARY HABERLAND PHONE NO : 407-273-7619 573 WATERSCAPE WAY SE DECISION MADE: 15-JUL-99 ORLANDO, FL 32808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC CAMERA GENZYME SURGICAL PRODUCTS CORP. 510(k) NO: K991416(TRADITIONAL) ATTN: MARY MCNAMARA CULLINANE PHONE NO : 508-643-0460 49 PLAIN STREET SE DECISION MADE: 20-JUL-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTEN GLOVCO (M) SDN. BHD. 510(k) NO: K991554(TRADITIONAL) ATTN: TAN PENG HOCK PHONE NO : 603 391 3888 LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 09-JUL-99 OFF JALAN MERU 510(k) STATEMENT KLANG, SELANGOR D.E., MALAYSIA 42100 DEVICE: GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE GREINER MEDITECH, INC. 510(k) NO: K992244(TRADITIONAL) ATTN: DOUG HARRIS PHONE NO : 410-836-8228 260 GATEWAY DRIVE, SUITE 17A SE DECISION MADE: 26-JUL-99 BEL AIR, MD 21014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) HARRY J. BOSWORTH CO. 510(k) NO: K991489(TRADITIONAL) ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 15-JUL-99 SKOKIE, IL 60076 510(k) STATEMENT DEVICE: ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) HARRY J. BOSWORTH CO. 510(k) NO: K991490(TRADITIONAL) ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 15-JUL-99 SKOKIE, IL 60076 510(k) STATEMENT DEVICE: FASTRAY LC HARRY J. BOSWORTH CO. 510(k) NO: K991631(TRADITIONAL) ATTN: MILDRED J BOSWORTH PHONE NO : 847-679-3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 26-JUL-99 SKOKIE, IL 60076 510(k) STATEMENT DEVICE: CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CON HARTALEGA SDN BHD 510(k) NO: K991616(TRADITIONAL) ATTN: KUAN KAM HON PHONE NO : 036 342 177 9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 14-JUL-99 KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 52100 DEVICE: HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MO HEWLETT-PACKARD GMBH 510(k) NO: K990476(TRADITIONAL) ATTN: EGON PFEIL PHONE NO : 703-114-2243 HERRENBERGER STR. 110-140 SE DECISION MADE: 22-JUL-99 BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS HITACHI MEDICAL CORP. OF AMERICA 510(k) NO: K991535(TRADITIONAL) ATTN: GARY W ENOS PHONE NO : 330-405-3330 9177 DUTTON DR. SE DECISION MADE: 30-JUL-99 TWINSBURG, OH 44056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS ACCP SYSTEM LINE EXTENSION HOWMEDICA OSTEONICS CORP. 510(k) NO: K992344(SPECIAL) ATTN: KATE SUTTON PHONE NO : 201-934-4386 59 ROUTE 17 SE DECISION MADE: 30-JUL-99 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K990712 (TRADITIONAL) ATTN: MS. KAREN ARIEMMA PHONE NO: 201-760-8187 59 ROUTE 17 SE DECISION MADE: 29-JUL-99 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID IC HUMAGEN FERTILITY DIAGNOSTICS, INC510(k) NO: K990847(TRADITIONAL) ATTN: CINDY SHOWALTER PHONE NO : 804-979-4000 2400 HUNTER'S WAY SE DECISION MADE: 14-JUL-99 CHARLOTTESVILLE, VA 22911 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS HUMAGEN FERTILITY DIAGNOSTICS, INC510(k) NO: K990941(TRADITIONAL) ATTN: CINDY SHOWALTER PHONE NO : 804-979-4000 2400 HUNTER'S WAY SE DECISION MADE: 14-JUL-99 CHARLOTTESVILLE, VA 22911 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM ICS MEDICAL CORP. 510(k) NO: K991497(TRADITIONAL) ATTN: DELMAR F BLOEM PHONE NO : 800-289-2150 2227 HAMMOND DR. SE DECISION MADE: 28-JUL-99 SCHAUMBURG, IL 60173-3860 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELOGENE RAPID MRSA IDENTIFICATION ASSAY ID BIOMEDICAL CORP. 510(k) NO: K990640(TRADITIONAL) ATTN: ROBERT N BRYAN PHONE NO : 604 431 9314 8855 NORTHBROOK COURT SE DECISION MADE: 09-JUL-99 BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSFX MULTI PIN CLAMP IMMEDICA, INC. 510(k) NO: K991723(TRADITIONAL) ATTN: ROY BOGERT PHONE NO : 973-635-9040 100 PASSAIC AVE. SE DECISION MADE: 22-JUL-99 CHATHAM, NJ 07928-2848 510(k) STATEMENT DEVICE: RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 IMMUNO CONCEPTS, INC. 510(k) NO: K992041(TRADITIONAL) ATTN: ERIC S HOY PHONE NO : 972-247-3616 2280 SPRINGLAKE ROAD SE DECISION MADE: 23-JUL-99 SUITE 106 510(k) SUMMARY AVAILABLE FROM FDA DALLAS, TX 75234 DEVICE: HEDROCEL ACETABULAR CAGE SYSTEM IMPLEX CORP. 510(k) NO: K983837(TRADITIONAL) ATTN: ROBERT POGGIE PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 01-JUL-99 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBREX HIP STEM, MODEL 01-128-XXXXX IMPLEX CORP. 510(k) NO: K991869(ABBREVIATED) ATTN: ROBERT POGGIE PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 14-JUL-99 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRIT-LINE MONITOR III (CLM III) IN-LINE DIAGNOSTICS CORP. 510(k) NO: K992227(SPECIAL) ATTN: MATTHEW L HAYNIE PHONE NO : 801-451-9000 117 W. 200 S. SE DECISION MADE: 30-JUL-99 FARMINGTON, UT 84025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYO-MONO CRYOGRNIC SYSTEM INFLUENCE, INC. 510(k) NO: K991122(TRADITIONAL) ATTN: PETER M BICK PHONE NO : 415-546-7700 71 STEVENSON ST., SUITE 1120 SE DECISION MADE: 01-JUL-99 SAN FRANCISCO, CA 94105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAPLETAC BONE ANCHOR SYSTEM INFLUENCE, INC. 510(k) NO: K992277(SPECIAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 30-JUL-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-INTERFERENCE SCREW INNOVASIVE DEVICES, INC. 510(k) NO: K990454(TRADITIONAL) ATTN: KATHLEEN MORAHAN PHONE NO : 588-460-8229 734 FOREST ST. SE DECISION MADE: 01-JUL-99 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANESFLOW-DUAL DRIP IV INFUSION SET INNOVATIVE DESIGN ASSOC. 510(k) NO: K990496(TRADITIONAL) ATTN: JERRY D VLOKA PHONE NO : 201-760-9550 561 EAST SADDLE RIVER SE DECISION MADE: 01-JUL-99 UPPER SADDLE RIVER, NJ 07458 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIDESTREAM NEBULIZER INSPIRED MEDICAL PRODUCTS LTD. 510(k) NO: K991725(TRADITIONAL) ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 30-JUL-99 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K983631(TRADITIONAL) ATTN: EDWARD C HOREY, JR. PHONE NO : 412-854-1133 2990 INDUSTRIAL BLVD. SE DECISION MADE: 01-JUL-99 BETHEL PARK, PA 15102 510(k) STATEMENT DEVICE: DURAGEN DURAL GRAFT MATRIX INTEGRA LIFESCIENCES CORP. 510(k) NO: K982180(TRADITIONAL) ATTN: JUDITH E O'GRADY PHONE NO : 609-275-0500 105 MORGAN LN. SE DECISION MADE: 06-JUL-99 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE INTEGRA LIFESCIENCES CORP. 510(k) NO: K992216(SPECIAL) ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311 105 MORGAN LANE SE DECISION MADE: 26-JUL-99 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) INVACARE CORP. 510(k) NO: K984295(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 ONE INVACARE WAY SE DECISION MADE: 09-JUL-99 P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA ELYRIA, OH 44036-2125 DEVICE: SPERM MAINTENANCE MEDIUM WITH GLYCEROL IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991337(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 949-261-7800 2511 DAIMLER ST. SE DECISION MADE: 08-JUL-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOVINE SERUM ALBUMIN (BSA) IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991338(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 14-JUL-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991341(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 08-JUL-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991342(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 08-JUL-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVP (POLYVINYLPYRROLIDONE) IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991343(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 14-JUL-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED HAM'S F-10 WITH ALBUMIN IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991420(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 02-JUL-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGER IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991421(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 02-JUL-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOLUX SURGICAL HEADLIGHT ISOLUX AMERICA 510(k) NO: K991572(TRADITIONAL) ATTN: STUART L MCGHEE PHONE NO : 941-514-7475 1479 RAILHEAD BLVD. SE DECISION MADE: 08-JUL-99 NAPLES, FL 34110-8444 510(k) STATEMENT DEVICE: CODMAN MICROSENSOR VENTRICULAR CATHETER KIT JOHNSON & JOHNSON PROFESSIONALS, I510(k) NO: K991222(TRADITIONAL) ATTN: JAMES M FLAHERTY PHONE NO : 508-880-8404 325 PARAMOUNT DR. SE DECISION MADE: 09-JUL-99 RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K992218(TRADITIONAL) ATTN: KEVIN P PRARIO PHONE NO : 781-834-9500 180 ENTERPRISE DR. SE DECISION MADE: 30-JUL-99 MARSHFIELD, MA 02050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOMET XK-95 PERFORATOR MOTOR (MI-102) KOMET MEDICAL 510(k) NO: K991625(TRADITIONAL) ATTN: COURTNEY S PARADICE PHONE NO : 805-658-8755 2188 KNOLL DRIVE SE DECISION MADE: 30-JUL-99 VENTURA, CA 93003 510(k) STATEMENT DEVICE: VISER PENILE TUMESCENCE MONITOR LABORIE MEDICAL TECH CORP. 510(k) NO: K991479(TRADITIONAL) ATTN: DALE COLEMAN PHONE NO : 802-878-1110 310 HURRICANE LANE #2 SE DECISION MADE: 07-JUL-99 WILLISTON, VT 05495 510(k) STATEMENT DEVICE: LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABE LAGLOVE (M) SDN. BHD. 510(k) NO: K992018(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 5411 LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 30-JUL-99 OFF BATU 13, JALAN CHERAS 510(k) STATEMENT KAJANG, SELANGOR, D.E., MALAYSIA 43000 DEVICE: SCATTERFREE LATERAL EMITTING FIBER LASER PERIPHERALS, INC. 510(k) NO: K992083(SPECIAL) ATTN: NANCY L ARNOLD PHONE NO : 612-930-9065 5484 FELTL RD. SE DECISION MADE: 12-JUL-99 MINNETONKA, MN 55343 510(k) STATEMENT DEVICE: PULSTAR LASERMED, INC. 510(k) NO: K992061(TRADITIONAL) ATTN: CALVIN D OSTLER PHONE NO : 801-256-0074 8050 SOUTH 1300 WEST SE DECISION MADE: 30-JUL-99 WEST JORDAN, UT 84088 510(k) STATEMENT DEVICE: REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM LIFECORE BIOMEDICAL, INC. 510(k) NO: K991114(TRADITIONAL) ATTN: CAROLYN ANDERSON PHONE NO : 612-368-6324 3515 LYMAN BLVD. SE DECISION MADE: 14-JUL-99 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E9000 SYSTEM LINVATEC CORP. 510(k) NO: K990524(TRADITIONAL) ATTN: LAURA SENEFF PHONE NO : 727-392-6464 11311 CONCEPT BOULEVARD SE DECISION MADE: 15-JUL-99 LARGO, FL 34643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIORC ANCHOR LINVATEC CORP. 510(k) NO: K990770(TRADITIONAL) ATTN: LAURA SENEFF PHONE NO : 727-392-6464 11311 CONCEPT BOULEVARD SE DECISION MADE: 30-JUL-99 LARGO, FL 34643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, LUCAS MEDICAL INC. 510(k) NO: K983802(TRADITIONAL) ATTN: DANIEL LUCAS PHONE NO : 714-938-0233 1751 SOUTH DOUGLASS ROAD SE DECISION MADE: 30-JUL-99 ANAHEIM, CA 92806 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, S LUDLOW TECHNICAL PRODUCTS 510(k) NO: K991235(TRADITIONAL) ATTN: KATHLEEN M MURPHY PHONE NO : 413-593-8288 TWO LUDLOW PARK SE DECISION MADE: 08-JUL-99 CHICOPEE, MA 01022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE MAXXIM MEDICAL, INC. 510(k) NO: K991615(TRADITIONAL) ATTN: JOYCE MOODY PHONE NO : 813-814-4817 477 COMMERCE BLVD SE DECISION MADE: 30-JUL-99 OLDSMAR, FL 34677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE MAXXIM MEDICAL, INC. 510(k) NO: K992122(TRADITIONAL) ATTN: PETER GRAHAM PHONE NO : 727-561-2100 477 COMMERCE BLVD SE DECISION MADE: 15-JUL-99 OLDSMAR, FL 34677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS MCKINLEY, INC. 510(k) NO: K991275(TRADITIONAL) ATTN: JOHN MCINROY PHONE NO : 303-420-9569 4080 YOUNGFIELD ST. SE DECISION MADE: 01-JUL-99 WHEAT RIDGE, CO 80033 510(k) STATEMENT DEVICE: UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES MEDART CORP. 510(k) NO: K991297(TRADITIONAL) ATTN: MARILYN M CHOU PHONE NO : 510-832-2130 11772 SORRENTO VALLEY RD. SE DECISION MADE: 12-JUL-99 SUITE 240 510(k) STATEMENT SAN DIEGO, CA 92121 DEVICE: UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES MEDART CORP. 510(k) NO: K991659(TRADITIONAL) ATTN: MARILYN M CHOU PHONE NO : 510-832-2130 11772 SORRENTO VALLEY RD. SE DECISION MADE: 29-JUL-99 SUITE 240 510(k) STATEMENT SAN DIEGO, CA 92121 DEVICE: QUADRATURE WRIST COIL, MODEL 445PH-64 MEDICAL ADVANCES, INC. 510(k) NO: K991434(TRADITIONAL) ATTN: THOMAS E TYNES PHONE NO : 414-258-3808 10437 INNOVATION DR. SE DECISION MADE: 06-JUL-99 MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAP MEDICAL INSTRUMENTATION & DIAGNOST510(k) NO: K991336(TRADITIONAL) ATTN: TYRONE L HARDY PHONE NO : 619-558-5880 5995 MIRA MESA BLVD. SE DECISION MADE: 12-JUL-99 SUITE B 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSULSCAN INSULATION TESTING SYSTEM MEDICOR CORP. 510(k) NO: K991424(TRADITIONAL) ATTN: SCOTT B KERRIGAN PHONE NO : 847-918-8445 150 FAIRWAY DR. SE DECISION MADE: 22-JUL-99 SUITE 164 510(k) SUMMARY AVAILABLE FROM FDA VERNON HILLS, IL 60090 DEVICE: PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BL MEDISENSE, INC. 510(k) NO: K983504(TRADITIONAL) ATTN: MICHAEL HALPIN PHONE NO : 781-276-6289 4-A CROSBY DR. SE DECISION MADE: 09-JUL-99 BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER MEDISON AMERICA, INC. 510(k) NO: K984639(TRADITIONAL) ATTN: BOB LEIKER PHONE NO : 925-463-2166 6616 OWENS DR. SE DECISION MADE: 12-JUL-99 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDO MEDISON AMERICA, INC. 510(k) NO: K992155(TRADITIONAL) ATTN: MICHAELA MAHL PHONE NO : 925-463-1830 6616 OWENS DR. SE DECISION MADE: 08-JUL-99 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD MEDITEC CO., LTD. 510(k) NO: K992328(TRADITIONAL) ATTN: D. H. CHANG PHONE NO : 823 427 072701 SE DECISION MADE: 21-JUL-99 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDITRON STETHOSCOPE SYSTEM MEDITRON AS 510(k) NO: K991367(TRADITIONAL) ATTN: CHARLES H KYPER PHONE NO : 301-776-3546 11902 SIMPSON ROAD SE DECISION MADE: 19-JUL-99 CLARKSVILLE, MD 21029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRAD VISTRON CT INJECTOR SYSTEM MEDRAD, INC. 510(k) NO: K991557(SPECIAL) ATTN: JAN E DOBSCHA PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 21-JUL-99 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM MEDSYS, INC. 510(k) NO: K991211(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SOUTH SE DECISION MADE: 08-JUL-99 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K991389(TRADITIONAL) ATTN: ANN-CHRISTINE JONSSON PHONE NO : 454 457 9000 TONSBAKKEN 16-18 SE DECISION MADE: 15-JUL-99 SKOVLUNDE 510(k) SUMMARY AVAILABLE FROM FDA COPENHAGEN, DENMARK DK-2740 DEVICE: MODIFICATION TO FOUNTAIN INFUSION SYSTEM MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K992231(SPECIAL) ATTN: CHESTER MCCOY PHONE NO : 801-253-2600 1600 WEST MERIT PKWY. SE DECISION MADE: 23-JUL-99 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET METRIKA, INC. 510(k) NO: K991917(TRADITIONAL) ATTN: YA-CHEN HSU PHONE NO : 408-524-2255 510 OAKMEAD PARKWAY SE DECISION MADE: 12-JUL-99 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTI 1 ML SYRINGE MICRO THERAPEUTICS, INC. 510(k) NO: K991225(ABBREVIATED) ATTN: MARIA D OCHOA PHONE NO : 949-837-3700 1062-F CALLE NEGOCIO SE DECISION MADE: 08-JUL-99 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICK-SERTER, MODEL 395 MINIMED TECHNOLOGIES, INC. 510(k) NO: K992300(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 818-362-5958 12744 SAN FERNANDO RD. SE DECISION MADE: 29-JUL-99 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TRUZONE PEAK FLOW METER MONAGHAN MEDICAL CORP. 510(k) NO: K991212(ABBREVIATED) ATTN: JAMES A COCHIE PHONE NO : 518-561-7330 5 LATOUR AVE., SUITE 1600 SE DECISION MADE: 01-JUL-99 P.O. BOX 2805 510(k) STATEMENT PLATTSBURGH, NY 12901 DEVICE: EXCELL 22 MWI, INC. 510(k) NO: K991539(TRADITIONAL) ATTN: GREGORY A WITHERSPOON PHONE NO : 214-210-4900 4230 SHILLING WAY SE DECISION MADE: 01-JUL-99 DALLAS, TX 75237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AHMED GLAUCOMA VALVE IMPLANT NEW WORLD MEDICAL, INC. 510(k) NO: K991072(TRADITIONAL) ATTN: A.M. AHMED PHONE NO : 909-466-4304 10763 EDISON COURT SE DECISION MADE: 13-JUL-99 RANCHO CUCAMONGA, CA 91730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIN SNAP-OFF SCREW NEWDEAL S.A. 510(k) NO: K991477(TRADITIONAL) ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899 9109 COPENHAVER DRIVE SE DECISION MADE: 14-JUL-99 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVE, POWDERED, BLUE NING BO YUJIANG RUBBER & PLASTIC C510(k) NO: K991821(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 01-JUL-99 SPARKS,, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRO MECHANICAL LITHOTRIPTOR NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K990341(TRADITIONAL) ATTN: CASSY KUREK PHONE NO : 847-608-8900 600 CHURCH RD. SE DECISION MADE: 14-JUL-99 ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAT PROFILE M7 ANALYZER NOVA BIOMEDICAL CORP. 510(k) NO: K991727(TRADITIONAL) ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800 200 PROSPECT ST. SE DECISION MADE: 16-JUL-99 WALTHAM, MA 02254-9141 510(k) STATEMENT DEVICE: COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) NOVARTIS NUTRITION CORP. 510(k) NO: K991668(TRADITIONAL) ATTN: ROBERT J LANG PHONE NO : 612-591-2950 5320 WEST 23RD STREET SE DECISION MADE: 26-JUL-99 PO BOX 370 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55440 DEVICE: SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPT OHIO MEDICAL INSTRUMENT CO., INC. 510(k) NO: K991267(TRADITIONAL) ATTN: KENNETH B MILLER PHONE NO : 513-561-2705 4900 CHARLEMAR DR. SE DECISION MADE: 12-JUL-99 CINCINNATI, OH 45227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROCAR SYSTEM ACCORDING TO HASSON OLYMPUS AMERICA, INC. 510(k) NO: K990237(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 12-JUL-99 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER OMNISONICS MEDICAL TECHNOLOGIES 510(k) NO: K991377(TRADITIONAL) ATTN: DEEBIE IAMPIETRO PHONE NO : 978-664-8400 14 EQUESTRIAN DR SE DECISION MADE: 12-JUL-99 N. READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCLERAL PLUGS, 19 AND 20 GAUGE OPHTHALMIC CONSULTANTS, INC. 510(k) NO: K990872(TRADITIONAL) ATTN: JOHN E LINCOLN PHONE NO : 435-882-4655 65 N. MAIN, SUITE 101 SE DECISION MADE: 13-JUL-99 PO BOX 154 510(k) SUMMARY AVAILABLE FROM FDA TOOELE, UT 84074 DEVICE: BICORTICAL SCREW ORALTRONICS MARKETING-UND VERTRIEB510(k) NO: K983120(TRADITIONAL) ATTN: FLOYD G LARSON PHONE NO : 619-792-1235 4329 GRAYDON RD SE DECISION MADE: 29-JUL-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT ORATEC INTERVENTIONS, INC. 510(k) NO: K992408(SPECIAL) ATTN: SHEILA RAMERMAN PHONE NO : 650-369-9904 3700 HAVEN CT. SE DECISION MADE: 30-JUL-99 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUNT TIP TROCAR PORT ORIGIN MEDSYSTEMS, INC. 510(k) NO: K992353(TRADITIONAL) ATTN: LORI E ADELS PHONE NO : 650-470-6230 1525 O'BRIEN DR. SE DECISION MADE: 30-JUL-99 MENLO PARK, CA 94025 510(k) STATEMENT DEVICE: SERUM CROSSLAPS ONE STEP ELISA OSTEOMETER BIOTECH A/S 510(k) NO: K990843(TRADITIONAL) ATTN: PER QVIST PHONE NO : 454 494 8900 HERLEV HOVEDGADE 207 SE DECISION MADE: 09-JUL-99 HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS HA-COATED DEVICES OSTEONICS CORP. 510(k) NO: K980070(TRADITIONAL) ATTN: TERRY SHERIDAN PHONE NO : 281-825-4900 59 ROUTE 17 SE DECISION MADE: 23-JUL-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) OSTEOTECH, INC. 510(k) NO: K991586(TRADITIONAL) ATTN: CHRISTOPHER TALBOT PHONE NO : 800-537-9842 51 JAMES WAY SE DECISION MADE: 23-JUL-99 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-LEG (3C100) OTTO BOCK ORTHOPEDIC INDUSTRY, INC510(k) NO: K991590(TRADITIONAL) ATTN: JOHN HENDRICKSON PHONE NO : 612-533-9464 3000 XENIUM LANE NORTH SE DECISION MADE: 08-JUL-99 MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARKER FLEX-TIP TRACHEAL TUBE PARKER MEDICAL ASSOC. 510(k) NO: K984528(TRADITIONAL) ATTN: JEFFREY D PARKER PHONE NO : 513-321-1097 109 INVERNESS DRIVE EAST, SE DECISION MADE: 15-JUL-99 SUITE J 510(k) SUMMARY AVAILABLE FROM FDA ENGLEWOOD, CO 80112-5105 DEVICE: ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS PDZ-EUROPA LTD. 510(k) NO: K992163(SPECIAL) ATTN: ROBERT F MARTIN PHONE NO : 978-369-0617 325COLLEGE ROAD SE DECISION MADE: 13-JUL-99 CONCORD, MA 01742 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICAT PERIPHERAL AVE 510(k) NO: K991533(TRADITIONAL) ATTN: SUSAN WALTON PHONE NO : 707-591-7315 2330 CIRCADIAN WAYY SE DECISION MADE: 29-JUL-99 SANTA ROSA, CA 95407-5415 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9175 PHAMATECH 510(k) NO: K992217(SPECIAL) ATTN: CARL A MONGIOVI PHONE NO : 9265 ACTIVITY RD., #112-113 SE DECISION MADE: 13-JUL-99 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 PHARMACIA & UPJOHN CO. 510(k) NO: K991945(TRADITIONAL) ATTN: KAREN E MATIS PHONE NO : 614-794-3324 5094 ST. ANDREWS DRIVE SE DECISION MADE: 28-JUL-99 WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEWPOINT TOOLS- STERRAD PICKER INTERNATIONAL, INC. 510(k) NO: K983764(TRADITIONAL) ATTN: HELEN K KEELER PHONE NO : 440-473-5591 595 MINER RD. SE DECISION MADE: 08-JUL-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MR SPECTROSCOPY PACKAGE PICKER INTERNATIONAL, INC. 510(k) NO: K991568(TRADITIONAL) ATTN: ELAINE K KEELER PHONE NO : 440-473-5591 595 MINER RD. SE DECISION MADE: 19-JUL-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM PLUS ORTHOPEDICS 510(k) NO: K982859(TRADITIONAL) ATTN: HARTMUT LOCH PHONE NO : 619-455-2400 3550 GENERAL ATOMICS CT. SE DECISION MADE: 30-JUL-99 BLDG. 15-100 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121-1194 DEVICE: CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X PRECISION BIOLOGIC 510(k) NO: K990579(TRADITIONAL) ATTN: SANDY MORRISON PHONE NO : 902 468 6422 900 WINDMILL RD., SUITE 100 SE DECISION MADE: 23-JUL-99 DARTMOUTH, N.S., CANADA B3B 1P7 510(k) STATEMENT DEVICE: CRYOCHECK LA SURE, MODEL SUR25-10 PRECISION BIOLOGIC 510(k) NO: K990580(TRADITIONAL) ATTN: SANDY MORRISON PHONE NO : 902 468 6422 900 WINDMILL RD., SUITE 100 SE DECISION MADE: 28-JUL-99 DARTMOUTH, N.S., CANADA B3B 1P7 510(k) STATEMENT DEVICE: PVS 1400 GUIDEWIRE PRECISION VASCULAR SYSTEMS, INC. 510(k) NO: K990823(TRADITIONAL) ATTN: JOHN RAGAZZO PHONE NO : 801-585-7069 360 WAKARA WAY SE DECISION MADE: 23-JUL-99 SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STATUS STIK, ACCUSIGN STIK PRINCETON BIOMEDITECH CORP. 510(k) NO: K992068(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 06-JUL-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEM PROCATH CORP. 510(k) NO: K991001(SPECIAL) ATTN: JOSEPH C GRIFFIN, III PHONE NO : 609-753-8533 COOPER RUN EXECUTIVE PARK SE DECISION MADE: 15-JUL-99 575 RT. 73 NORTH, BLDG. D 510(k) STATEMENT WEST BERLIN, NJ 08091 DEVICE: PASS/FAIL CHALLENGE PACK PROPPER MFG. CO., INC. 510(k) NO: K991276(TRADITIONAL) ATTN: JOHN D DYCKMAN PHONE NO : 718-392-6650 36-04 SKILLMAN AVE. SE DECISION MADE: 12-JUL-99 LONG ISLAND CITY, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LAR PT. BERLIAN GLOVINDO 510(k) NO: K992177(TRADITIONAL) ATTN: TONY JAP PHONE NO : 626-913-1798 JLN. RAYA MEDAN RANTAU PRAPAT SE DECISION MADE: 29-JUL-99 KM +230 DESA DAMULI 510(k) SUMMARY AVAILABLE FROM FDA KEC. LABUHAN BATU - N. SUMATRA, INDONESIA DEVICE: QUALISYS PSA IMMUNOASSAY QUALISYS DIAGNOSTICS, INC. 510(k) NO: K990234(TRADITIONAL) ATTN: GRACE KWAN PHONE NO : 949-788-0633 16 TECHNOLOGY DRIVE SE DECISION MADE: 08-JUL-99 SUITE 118 510(k) SUMMARY AVAILABLE FROM FDA IRVINE, CA 92618 DEVICE: MODIFICATION TO GAMMA GUIDANCE SYSTEM RADIATION MONITORING DEVICES, INC.510(k) NO: K983768(TRADITIONAL) ATTN: PAUL STOPPEL PHONE NO : 617-929-1167 44 HUNT ST. SE DECISION MADE: 02-JUL-99 WATERTOWN, MA 02472-4699 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TLC PEDIATRIC FRAME, MODEL TLC-SYS RADIONICS, INC. 510(k) NO: K991523(TRADITIONAL) ATTN: NANCY C MACDONALD PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 30-JUL-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDI-TEST COCAINE REDWOOD BIOTECH INC. 510(k) NO: K991110(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 408-541-8970 520 WEDDELL DRIVE, SUITE 8 SE DECISION MADE: 26-JUL-99 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDI-TEST METHAMPHETAMINE REDWOOD BIOTECH INC. 510(k) NO: K991504(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 650-691-4770 2440 LEGHORN ST. SE DECISION MADE: 22-JUL-99 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SULLIVAN AUTOSET NASAL CPAP SYSTEM RESMED LTD. 510(k) NO: K984428(TRADITIONAL) ATTN: SCOTT DUDEVOIR PHONE NO : 619-689-2400 10121 CARROLL CANYON RD SE DECISION MADE: 26-JUL-99 SAN DIEGO, CA 92131 510(k) STATEMENT DEVICE: GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720 RI MOS. S.R.L. 510(k) NO: K991827(TRADITIONAL) ATTN: ADENA NORA S RIEMER PHONE NO : 978-371-0066 100 MAIN ST. SE DECISION MADE: 19-JUL-99 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA CONCORD, MA DEVICE: COBAS INTEGRA AMIKACIN MAB ROCHE DIAGNOSTICS CORP. 510(k) NO: K991597(TRADITIONAL) ATTN: LISA GERARD PHONE NO : 317-576-3362 9115 HAGUE RD. SE DECISION MADE: 22-JUL-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA ACETAMINOPHEN ROCHE DIAGNOSTICS CORP. 510(k) NO: K991598(TRADITIONAL) ATTN: LISA GERARD PHONE NO : 317-576-3362 9115 HAGUE RD. SE DECISION MADE: 22-JUL-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTE-LITE I LIGHT CURE UNIT ROLENCE ENTERPRISE CO. LTD. 510(k) NO: K991863(TRADITIONAL) ATTN: STERLING CHENG PHONE NO : 886 346 31999 18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 19-JUL-99 CHUNGLI, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: Q-LITE 75 LIGHT CURE UNIT ROLENCE ENTERPRISE CO. LTD. 510(k) NO: K991865(TRADITIONAL) ATTN: STERLING CHENG PHONE NO : 886 344 631999 18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 20-JUL-99 CHUNGLI, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: DD URETERAL STENT, INTEGRAL STENT RUSCH INTL. 510(k) NO: K982974(TRADITIONAL) ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706 TALL PINES PARK SE DECISION MADE: 02-JUL-99 JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION SAFESKIN CORP. 510(k) NO: K991951(TRADITIONAL) ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010 12671 HIGH BLUFF DR. SE DECISION MADE: 26-JUL-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAMSUNG RAYPAX SYSTEM SAMSUNG SDS CO., LTD 510(k) NO: K991537(TRADITIONAL) ATTN: HERMAN OOSTERWJICK PHONE NO : 940-440-9330 2001 EAST OAKSHORES DRIVE SE DECISION MADE: 06-JUL-99 CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION P SCAN-MED, INC. 510(k) NO: K991700(TRADITIONAL) ATTN: EDWARD C WILSON PHONE NO : 202-637-5839 555 13TH STREET, N.W. SE DECISION MADE: 19-JUL-99 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS SCHIAPPARELLI BIOSYSTEMS, INC. 510(k) NO: K991733(TRADITIONAL) ATTN: STEVEN DALESSIO PHONE NO : 973-882-8630 368 PASSAIC AVE. SE DECISION MADE: 13-JUL-99 FAIRFIELD, NJ 07004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCIMED ANGIOGRAPHIC CATHETERS SCIMED 510(k) NO: K992142(SPECIAL) ATTN: MELANIE RASKA PHONE NO : 800-553-5878 ONE SCIMED PLACE SE DECISION MADE: 21-JUL-99 MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K991849(TRADITIONAL) ATTN: CHAN CHIN HONG PHONE NO : 605 322 3200 LT 72706, JALAN LAHAT, KAWASAN SE DECISION MADE: 07-JUL-99 PERINDUSTRIAN BUKIT MERAH 510(k) STATEMENT LAHAT, IPOH, PERAK, MALAYSIA 31500 DEVICE: LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM SHANGHAI CHANGZHENG LATEX FACTORY 510(k) NO: K992031(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 12-JUL-99 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES SHANGHAI CHINASTAR CORP. 510(k) NO: K992205(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD SE DECISION MADE: 23-JUL-99 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANGHAI CHINASTAR CORP. 510(k) NO: K992206(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD SE DECISION MADE: 29-JUL-99 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K991457(TRADITIONAL) ATTN: DANNY WANG PHONE NO : 011 862 157727722 #1 BIYU RD.,CANGQIAO TOWNSHIP SE DECISION MADE: 01-JUL-99 SONGJIANG COUNTY 510(k) STATEMENT SHANGHAI, CHINA DEVICE: PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K992100(TRADITIONAL) ATTN: DANNY WANG PHONE NO : 011 862 157727722 #1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 29-JUL-99 SONGJIANG SHANGHAI, CHINA 510(k) STATEMENT DEVICE: SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. SHELHIGH, INC. 510(k) NO: K991567(TRADITIONAL) ATTN: SHLOMO GABBAY PHONE NO : 973-467-7861 67 E. WILLOW STREET SE DECISION MADE: 14-JUL-99 MILLBURN, NJ 07041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EARLOOP FACE MASK SHUENN BAO SHING CORP. 510(k) NO: K990719(TRADITIONAL) ATTN: CHARLIE CHEN PHONE NO : 886 225 922288 11TH FL., 35, MIN CHUAN W. RD SE DECISION MADE: 12-JUL-99 TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: RABEA DEVICE, MODEL PXXXXXX SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K990345(TRADITIONAL) ATTN: THOMAS HOGHAUG PHONE NO : 612-470-9545 27660 WOODSIDE ROAD SE DECISION MADE: 30-JUL-99 SHOREWOOD, MN 55331 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETCHING GEL SILICON-UND COMPOSITE SPEZIALITATE510(k) NO: K991450(TRADITIONAL) ATTN: JURGEN ENGELBRECHT PHONE NO : 493 412 18619 ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 09-JUL-99 ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SD-100 SKYEAR THERMOMETER SKYLARK DEVICE CO., LTD. 510(k) NO: K984506(TRADITIONAL) ATTN: GEORGE K C CHEN PHONE NO : 886 225 979005 34 CHUNG SHAN NORTH RD., SE DECISION MADE: 29-JUL-99 12TH FL., SEC. 3 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES SMART GLOVE CORP. SDN BHD 510(k) NO: K991624(TRADITIONAL) ATTN: FOO KHON PU PHONE NO : 603 391 6100 LOT 6487 BATU 5 3/4 SE DECISION MADE: 09-JUL-99 SEMENTA, JALAN KAPAR 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: SMITH & NEPHEW SUTURE LOK SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K991500(TRADITIONAL) ATTN: SIGI CARON PHONE NO : 508-261-3600 130 FORBES BOULEVARD SE DECISION MADE: 14-JUL-99 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR SMITH & NEPHEW, INC. 510(k) NO: K991323(TRADITIONAL) ATTN: DEBORAH CONNORS PHONE NO : 978-749-1000 160 DASCOMB RD. SE DECISION MADE: 06-JUL-99 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGY POROUS SIZE 8 HIP STEM SMITH & NEPHEW, INC. 510(k) NO: K991485(ABBREVIATED) ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 BROOKS RD. SE DECISION MADE: 12-JUL-99 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CICACARE MANAGEMENT FOR SCARS SMITH & NEPHEW, INC. 510(k) NO: K991957(TRADITIONAL) ATTN: JIM IRVIN PHONE NO : 727-392-1261 11775 STARKEY RD. SE DECISION MADE: 20-JUL-99 LARGO, FL 33773-4727 510(k) STATEMENT DEVICE: CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. SMITH & NEPHEW, INC. 510(k) NO: K991968(TRADITIONAL) ATTN: JIM IRVIN PHONE NO : 727-392-1261 11775 STARKEY RD. SE DECISION MADE: 30-JUL-99 LARGO, FL 33773-4727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARIETENE POLYPROPYLENE MESH SOFRADIM PRODUCTION 510(k) NO: K991400(TRADITIONAL) ATTN: MARY MCNAMARA CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 12-JUL-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONT SPECIALTY ULTRAVISION, INC. 510(k) NO: K984090(TRADITIONAL) ATTN: IVALEE I COHEN PHONE NO : 408-341-0700 307 ORCHARD CITY DR., #100 SE DECISION MADE: 07-JUL-99 CAMPBELL, CA 95008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER STELKAST CO. 510(k) NO: K991622(TRADITIONAL) ATTN: DONALD A STEVENS PHONE NO : 412-322-8280 800 VINIAL STREET, SUITE B-210 SE DECISION MADE: 14-JUL-99 PITTSBURGH, PA 15212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNOCTA PROSTHETICS STRAUMANN USA 510(k) NO: K990342(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 RESERVOIR PLACE, SE DECISION MADE: 20-JUL-99 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02154 DEVICE: PRO-PORTION CLEANER/DISINFECTANT SULTAN CHEMISTS, INC. 510(k) NO: K991509(TRADITIONAL) ATTN: LES HEIMANN PHONE NO : 201-871-1232 85 WEST FOREST AVE. SE DECISION MADE: 14-JUL-99 ENGLEWOOD, NJ 07631 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HT, MODEL HT PB SULZER OSCOR, INC. 510(k) NO: K990142(TRADITIONAL) ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511 3816 DESOTO BLVD. SE DECISION MADE: 30-JUL-99 PALM HARBOR, FL 34683 510(k) STATEMENT DEVICE: OCUSYSTEM ART ADVANTAGE, MODEL 995 SURGICAL DESIGN CORP. 510(k) NO: K991852(TRADITIONAL) ATTN: WAYNE H MATELSKI PHONE NO : 202-857-6340 1050 CONNECTICUT AVENUE, NW SE DECISION MADE: 07-JUL-99 WASHINGTON, DC 20036-5339 510(k) STATEMENT DEVICE: IMMERGE IMAGE CORRELATION SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K991468(TRADITIONAL) ATTN: ROGER WHITE PHONE NO : 303-439-9709 530 COMPTON ST. SE DECISION MADE: 06-JUL-99 BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIBOND SOLO PLUS 2 SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K991808(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 09-JUL-99 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES CERVIFIX SYSTEM SYNTHES (USA) 510(k) NO: K990965(TRADITIONAL) ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700 P.O. BOX 0548 SE DECISION MADE: 01-JUL-99 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: SYNTHES CRANIAL FLAP TWIST CLAMP SYNTHES (USA) 510(k) NO: K991860(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 20-JUL-99 P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: SYNTHES CRANIAL FLAP TUBE CLAMP SYNTHES (USA) 510(k) NO: K992000(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 20-JUL-99 P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE SYNTRON BIORESEARCH, INC. 510(k) NO: K992207(TRADITIONAL) ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223 1420 LOS ANGELES AVE. SE DECISION MADE: 22-JUL-99 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA SIMI VALLEY, CA 93065 DEVICE: TAMPA HYPERBARIC MONOPLACE CHAMBER TAMPA HYPERBARIC ENT. 510(k) NO: K981938(TRADITIONAL) ATTN: MICHAEL CAPRIA PHONE NO : 813-935-4404 700 WEST WATERS AVE. SE DECISION MADE: 06-JUL-99 TAMPA, FL 33604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES TECSA TECHNICAL SERVICES 510(k) NO: K990602(TRADITIONAL) ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312 1205 DE LA VINA SE DECISION MADE: 01-JUL-99 SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX STERILE SURGICAL GLOVES TG MEDICAL SDN BHD 510(k) NO: K992219(TRADITIONAL) ATTN: WEE-CHAI LIM PHONE NO : 603 392 7880 LOT 5091, JALAN TERATAI, BT 5, SE DECISION MADE: 30-JUL-99 OFF JLN MERU 510(k) STATEMENT KLANG, SELANGOR D.E., MALAYSIA 41050 DEVICE: FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR THERMOQUEST CORP. 510(k) NO: K991408(TRADITIONAL) ATTN: RICHARD L MILLER PHONE NO : 740-373-4763 MILL CREEK ROAD SE DECISION MADE: 19-JUL-99 MARIETTA, OH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMOPLATE TOKAI HIT CO., LTD. 510(k) NO: K991263(TRADITIONAL) ATTN: HIDEHARU TSUCHIYA PHONE NO : 815 442 46699 306-1 GENDOJI-CHO SE DECISION MADE: 08-JUL-99 FUJINOMIYA-SHI, SHIZUOKA-KEN, JAPA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BISTITE II SC TOKUYAMA AMERICA, INC. 510(k) NO: K991711(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000 2000 M STREET NW SE DECISION MADE: 07-JUL-99 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036 DEVICE: TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 TRANSTRACHEAL SYSTEMS 510(k) NO: K982943(TRADITIONAL) ATTN: LEWIS W WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 12-JUL-99 BOULDER, CO 80301 510(k) STATEMENT DEVICE: ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING TREK DIAGNOSTICS SYSTEMS, INC. 510(k) NO: K972772(TRADITIONAL) ATTN: NADINE SULLIVAN PHONE NO : 800-871-8909 29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 13-JUL-99 WESTLAKE, OH 44145 510(k) STATEMENT DEVICE: OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODE TRIMEDYNE, INC. 510(k) NO: K992230(TRADITIONAL) ATTN: SUSAN H GAMBLE PHONE NO : 949-559-5300 2801 BARRANCA RD. SE DECISION MADE: 12-JUL-99 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSE TUTTNAUER USA CO. LTD. 510(k) NO: K990761(TRADITIONAL) ATTN: MARK M YACURA PHONE NO : 202-887-4071 1333 NEW HAMPSHIRE AVE., N.W. SE DECISION MADE: 09-JUL-99 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036 DEVICE: AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE TYCO INTL. (US), INC. 510(k) NO: K992288(TRADITIONAL) ATTN: CHRISTOPHER A GRAHAM PHONE NO : 203-845-1390 150 GLOVER AVE SE DECISION MADE: 30-JUL-99 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 UNITED PACIFIC CO., LTD. 510(k) NO: K991503(TRADITIONAL) ATTN: DANIEL YE HUA PHONE NO : 626-458-8518 219 SOUTH RAYMOND AVE. SE DECISION MADE: 28-JUL-99 ALHAMBRA, CA 91801 510(k) STATEMENT DEVICE: VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) VENTANA MEDICAL SYSTEMS INC. 510(k) NO: K990618(TRADITIONAL) ATTN: JUDITH FREDERICK PHONE NO : 520-690-2731 3865 N. BUSINESS CENTER DR. SE DECISION MADE: 23-JUL-99 TUCSON, AZ 85705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE VISTA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K991303(TRADITIONAL) ATTN: VICKI ANASTASI PHONE NO : 508-366-3668 134 FLANDERS RD. SE DECISION MADE: 12-JUL-99 WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPTFE RINGED GORE-TEX VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC 510(k) NO: K991602(TRADITIONAL) ATTN: TIMOTHY J RYAN PHONE NO : 800-437-8181 3450 WEST KILTIE LANE SE DECISION MADE: 09-JUL-99 FLAGSTAFF,, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE-TEX DUALMESH BIOMATERIAL W.L. GORE & ASSOCIATES,INC 510(k) NO: K992189(SPECIAL) ATTN: R, LARRY PRATT PHONE NO : 520-779-2771 3750 WEST KILTIE LN. SE DECISION MADE: 29-JUL-99 FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS MONITOR WELCH ALLYN, INC. 510(k) NO: K984033(TRADITIONAL) ATTN: ZORAN I PSENICNKI PHONE NO : 315-685-4400 4341 STATE STREET RD. SE DECISION MADE: 08-JUL-99 SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAP-WAVE 3000 (P07) WOM GMBH 510(k) NO: K990732(TRADITIONAL) ATTN: MICHAEL MCGRAIL PHONE NO : 508-337-2188 194 BRANCH ST SE DECISION MADE: 23-JUL-99 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS DIODE LASER SYSTEM AND ACCESSORIES XINTEC CORP. 510(k) NO: K990914(TRADITIONAL) ATTN: MARILYN M CHOU PHONE NO : 510-832-2130 900 ALICE ST. SE DECISION MADE: 30-JUL-99 OAKLAND, CA 94607 510(k) STATEMENT DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST ZEUS SCIENTIFIC, INC. 510(k) NO: K984180(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 20-JUL-99 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE ZIMMER, INC. 510(k) NO: K990135(TRADITIONAL) ATTN: KAREN CAIN PHONE NO : 219-372-4219 P.O. BOX 708 SE DECISION MADE: 12-JUL-99 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); ZIMMER, INC. 510(k) NO: K991581(TRADITIONAL) ATTN: STEPHEN MCKELVEY PHONE NO : 219-372-4944 P.O. BOX 708 SE DECISION MADE: 30-JUL-99 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ZYMED HOLTER 2000 ZYMED MEDICAL INSTRUMENTATION 510(k) NO: K992197(SPECIAL) ATTN: GRETEL LUMLEY PHONE NO : 800-235-5941 20 NORTH AVIADOR STREET SE DECISION MADE: 28-JUL-99 CAMARILLO, CA 93010 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 281 TOTAL WITH SUMMARIES 209 TOTAL WITH STATEMENTS 72
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