SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JUN-2006 THROUGH 30-JUN-2006 DEVICE: P.D .DECIMAL, INC. 510(k) NO: K061440(TRADITIONAL)
ATTN: DANIEL BENNETT PHONE NO : 407-330-3300 121 CENTRAL PARK PLACE SE DECISION MADE: 27-JUN-06 SANFORD, FL 32771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M LIQUID BANDAGE 3M COMPANY 510(k) NO: K053409(TRADITIONAL)
ATTN: BRYAN BECKER PHONE NO : 651-733-3373 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 19-JUN-06 ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. 510(k) NO: K061456(SPECIAL)
ATTN: JERRY WANG PHONE NO : 408-518-5113 1555 MCCANDLESS DR. SE DECISION MADE: 21-JUN-06 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY X-TRAC SYSTEM A. TITAN INSTRUMENTS, INC. 510(k) NO: K060691(TRADITIONAL)
ATTN: MICHAEL TUBER PHONE NO : 716-648-9272 97 MAIN ST. SE DECISION MADE: 12-JUN-06 HAMBURG, NY 14075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT AXSYM TROPONIN-I ADV ABBOTT LABORATORIES 510(k) NO: K060875(TRADITIONAL)
ATTN: MARGARET PROCHNIAK PHONE NO : 847-937-4106 100 ABBOTT PARK ROAD SE DECISION MADE: 14-JUN-06 ABBOTT PARK, IL 60064-3500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXSYM DIGOXIN III ABBOTT LABORATORIES 510(k) NO: K061249(SPECIAL)
ATTN: KENTON SMITH PHONE NO : 847-938-4807 D 9VA, BLDG. AP6C-2 SE DECISION MADE: 02-JUN-06 100 ABBOTT PARK RD 510(k) SUMMARY AVAILABLE FROM FDA ABBOTT PARK, IL 60064-3500 DEVICE: CREATININE ABBOTT LABORATORIES INC 510(k) NO: K061193(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1921 HURD DRIVE SE DECISION MADE: 23-JUN-06 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCIN UNI-KNEE SYSTEM ACCIN CORPORATION 510(k) NO: K060670(TRADITIONAL)
ATTN: MICHAEL KVITNITSKY PHONE NO : 973-777-8832 1033 US HIGHWAY 46 EAST SE DECISION MADE: 02-JUN-06 SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA CLIFTON, NJ 07013 DEVICE: ACELL POWDER WOUND DRESSING ACELL, INC 510(k) NO: K060888(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344 5600 WISCONSIN AVE. SE DECISION MADE: 23-JUN-06 SUITE 509 510(k) SUMMARY AVAILABLE FROM FDA CHEVY CHASE, MD 20815 DEVICE: ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET0 ACRO BIOTECH LLC. 510(k) NO: K053033(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-893-7749 9500 7TH STREET UNIT M SE DECISION MADE: 06-JUN-06 RANCHO CUCAMONGA, CA 91730-9094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# ACRO BIOTECH LLC. 510(k) NO: K053034(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-893-7749 9500 7TH STREET UNIT M SE DECISION MADE: 06-JUN-06 RANCHO CUCAMONGA, CA 91730-9094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 ACRO BIOTECH LLC. 510(k) NO: K053037(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-893-7749 9500 7TH STREET UNIT M SE DECISION MADE: 15-JUN-06 RANCHO CUCAMONGA, CA 91730-9094 510(k) STATEMENT DEVICE: ACUMEN SINGLE-LUMEN DELIVERY SHEATH ACUMEN MEDICAL, INC. 510(k) NO: K053400(TRADITIONAL)
ATTN: MARYBETH GAMBER PHONE NO : 408-530-1810 275 SANTA ANA COURT SE DECISION MADE: 19-JUN-06 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUTE BONE SCREW ACUTE INNOVATIONS LLC 510(k) NO: K061206(TRADITIONAL)
ATTN: ALYSSA THOMAS PHONE NO : 503-686-7200 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 19-JUN-06 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA HILLSBORO, OR 97124 DEVICE: CALSET COMPOSITE HEATER ADDENT, INC. 510(k) NO: K061395(TRADITIONAL)
ATTN: JOSHUA FRIEDMAN PHONE NO : 203-778-0200 43 MIRY BROOK RD. SE DECISION MADE: 23-JUN-06 DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ART BRACHYTHERAPY APPLICATOR ADVANCED RADIATION THERAPY, LLC 510(k) NO: K060299(TRADITIONAL)
ATTN: RAYMOND BRICAULT PHONE NO : 978-663-7300 9 LINNELL CIRCLE SE DECISION MADE: 06-JUN-06 BILLERICA, MA 01820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 ALARA, INC. 510(k) NO: K061538(SPECIAL)
ATTN: DIANE KING PHONE NO : 510-315-5173 47505 SEABRIDGE DRIVE SE DECISION MADE: 30-JUN-06 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDONE-COCAINE-150 TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K053422(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 410-992-4734 9110 RED BRANCH ROAD SE DECISION MADE: 15-JUN-06 SUITE B 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21045 DEVICE: AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE AMSINO INTERNATIONAL, INC. 510(k) NO: K061039(TRADITIONAL)
ATTN: CHING CHING SEAH PHONE NO : 909-626-5888 855 TOWNE CENTER DR. SE DECISION MADE: 29-JUN-06 POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. 510(k) NO: K061178(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 12-JUN-06 QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANGER IRRIGATION FLUID WARMING SYSTEM ARIZANT HEALTHCARE INC. 510(k) NO: K060939(TRADITIONAL)
ATTN: DAVID WESTLIN PHONE NO : 952-947-1277 10393 WEST 70TH ST. SE DECISION MADE: 26-JUN-06 EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR ARTHROTEK, INC. 510(k) NO: K060693(TRADITIONAL) ATTN: LESTER F PADILLA PHONE NO : 574-372-1644 56 EAST BELL DR. SE DECISION MADE: 06-JUN-06 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY ASAHI INTECC CO., LTD. 510(k) NO: K060745(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252 1301 DOVE STREET, SUITE #350 SE DECISION MADE: 23-JUN-06 NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLWOUND AT SQUARED, LLC 510(k) NO: K053476(TRADITIONAL)
ATTN: JULIA C TIERNEY PHONE NO : 202-828-3427 1050 CONNECTICUT AVE., NW SE DECISION MADE: 26-JUN-06 WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ABUTMENT FOR ZIMMER INTERFACE ATLANTIS COMPONENTS, INC. 510(k) NO: K053373(TRADITIONAL)
ATTN: BETSY BROWN PHONE NO : 847-560-4406 8944 TAMAROA TERRACE SE DECISION MADE: 30-JUN-06 SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B&L L-BETA, MODEL WL-B1 B&L BIOTECH CO., LTD. 510(k) NO: K060347(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 05-JUN-06 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIACAP ULTRA DIALYSIS FLUID FILTER B. BRAUN MEDIZINTECHNOLOGIE GMBH 510(k) NO: K052764(TRADITIONAL)
ATTN: SCOTT J PEASE PHONE NO : 610-266-0500 901 MARCON BOULEVARD SE DECISION MADE: 09-JUN-06 ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGI BARRIERMED GLOVE CO. 510(k) NO: K061038(TRADITIONAL)
ATTN: VICTOR J RAGUCCI PHONE NO : 407-771-4424 155 TECHNOLOGY PARK SE DECISION MADE: 23-JUN-06 LAKE MARY, FL 32746 510(k) STATEMENT DEVICE: SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED BAUSCH & LOMB 510(k) NO: K061157(SPECIAL)
ATTN: DEBRA KETCHUM PHONE NO : 585-338-8638 1400 NORTH GOODMAN ST. SE DECISION MADE: 22-JUN-06 ROCHESTER, NY 14609-0450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MO BD BIOSCIENCES 510(k) NO: K060375(TRADITIONAL)
ATTN: CARTER NAVARRO PHONE NO : 408-432-9475 2350 QUME DR. SE DECISION MADE: 06-JUN-06 SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 BECKMAN COULTER, INC. 510(k) NO: K061282(SPECIAL)
ATTN: JENNIFER RUETHER PHONE NO : 952-368-7629 1000 LAKE HAZELTINE DR. SE DECISION MADE: 02-JUN-06 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-3 BECTON, DICKINSON & CO. 510(k) NO: K061355(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938 7 LOVETON CIR. SE DECISION MADE: 07-JUN-06 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATELIA ASPERGILLUS EIA, MODEL 62793 BIO-RAD 510(k) NO: K060641(TRADITIONAL)
ATTN: CHRISTOPHER BENTSEN PHONE NO : 425-881-8300 CLINICAL DIAGNOSTICS GROUP SE DECISION MADE: 02-JUN-06 6565 185TH AVENUE NE 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98052 DEVICE: THE DOUBLE GLOVE BIOBARRIER, INC. 510(k) NO: K060030(TRADITIONAL)
ATTN: DAVID W MULLIS PHONE NO : 770-207-9174 367 PLEASANT VALLEY RD. SE DECISION MADE: 27-JUN-06 P.O. BOX 39 510(k) SUMMARY AVAILABLE FROM FDA GOOD HOPE, GA 30641 DEVICE: MBCP GEL BIOMATLANTE 510(k) NO: K060732(TRADITIONAL)
ATTN: MYRIAM VINCENT PHONE NO : 332 280 02009 5, RUE EDOUARD BELIN SE DECISION MADE: 02-JUN-06 VIGNEUX DE BRETAGNE, FRANCE 44360 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSA-DIAL HUMERAL HEAD PROSTHESIS BIOMET MANUFACTURING CORP. 510(k) NO: K060716(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639 PO BOX 587 SE DECISION MADE: 12-JUN-06 56. E. BELL DRIVE 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: 36MM BIOLOX DELTA CERAMIC HEADS BIOMET, INC. 510(k) NO: K061312(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 06-JUN-06 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, BIOPRO, INC. 510(k) NO: K061089(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777 17 SEVENTEENTH ST. SE DECISION MADE: 20-JUN-06 PORT HURON, MI 48060 510(k) STATEMENT DEVICE: CARTO RMT EP NAVIGATION SYSTEM V8 BIOSENSE WEBSTER, INC. 510(k) NO: K060047(TRADITIONAL)
ATTN: DIANA THORSON PHONE NO : 800-729-9010 3333 DIAMOND CANYON RD. SE DECISION MADE: 19-JUN-06 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE TOX DRUG SCREEN, MODEL 94400 BIOSITE INCORPORATED 510(k) NO: K060791(TRADITIONAL)
ATTN: ROBIN WEINER PHONE NO : 858-805-2821 9975 SUMMERS RIDGE RD SE DECISION MADE: 22-JUN-06 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX BIOSPHERE MEDICAL, INC. 510(k) NO: K061171(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 02-JUN-06 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL INTERPOROUS BONYF AG 510(k) NO: K051342(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010 SE DECISION MADE: 02-JUN-06 510(k) STATEMENT DEVICE: MYTIS ARROW XXXX BRAINBASE CORPORATION 510(k) NO: K052254(TRADITIONAL)
ATTN: CRAIG R BRUNS PHONE NO : 925-973-0710 10 MONTECITO DR. SE DECISION MADE: 01-JUN-06 DANVILLE, CA 94526 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTORVISION SPINE BRAINLAB AG 510(k) NO: K053159(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680 AMMERTHALSTRASSE 8 SE DECISION MADE: 06-JUN-06 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORAL-B SONIC COMPLETE BRAUN GMBH 510(k) NO: K061351(TRADITIONAL)
ATTN: AMANDA HEFFERNAN PHONE NO : 617-463-9532 800 BOYLSTON ST SE DECISION MADE: 05-JUN-06 PRUDENTIAL TOWER BLDG FL 46 510(k) SUMMARY AVAILABLE FROM FDA BOSTON, MA 02199-8004 DEVICE: BREAS ISLEEP 20+ BREAS MEDICAL AB 510(k) NO: K061057(SPECIAL)
ATTN: KARL-JOHAN HOLM PHONE NO : 463 186 8800 FORETAGSVAGEN 1 SE DECISION MADE: 23-JUN-06 MOLNLYCKE, SWEDEN 435 33 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK CO BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K060402(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 334 31007 LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 09-JUN-06 BATU BELAH 510(k) SUMMARY AVAILABLE FROM FDA KLANG, SELANGOR, MALAYSIA 42100 DEVICE: BRIVANT GUIDEWIRE BRIVANT LIMITED 510(k) NO: K060551(TRADITIONAL)
ATTN: TOMAS FUREY PHONE NO : 011 353 91788960 4 WESTLINK COMMERCIAL PARK SE DECISION MADE: 07-JUN-06 ORANMORE, GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALMLIGHT 10, MODEL 001-00030 CAO GROUP, INC. 510(k) NO: K061341(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282 8683 SOUTH 700 WEST SE DECISION MADE: 12-JUN-06 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND CARDINAL HEALTH 200, INC. 510(k) NO: K061308(SPECIAL)
ATTN: LAVENIA FORD PHONE NO : 847-785-3323 1500 WAUKEGAN ROAD SE DECISION MADE: 05-JUN-06 MCGAW PARK, IL 60685 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WDS, SIZE 2 AND SIZE 2 CEFLA S.C.R.L. 510(k) NO: K061114(ABBREVIATED)
ATTN: CLAUDE BERTHOIN PHONE NO : 386-672-0450 110 E GRANADA BLVD. SE DECISION MADE: 06-JUN-06 SUITE 207 510(k) SUMMARY AVAILABLE FROM FDA ORMOND BEACH, FL 32176 DEVICE: BLOOD PRESSURE METER, MODEL CH-311B CITIZEN WATCH CO., LTD. 510(k) NO: K061161(SPECIAL)
ATTN: JOSEPH D EDMONDSON JR. PHONE NO : 202-672-5354 3000 K STREET, N.W., SUITE 500 SE DECISION MADE: 26-JUN-06 WASHINGTON, DC 20007 510(k) STATEMENT DEVICE: ULTRATINE TRANSBLEPH COAPT SYSTEMS, INC. 510(k) NO: K060248(TRADITIONAL)
ATTN: LINDA RUEDY PHONE NO : 650-461-7647 1820 EMBARCADERO RD. SE DECISION MADE: 12-JUN-06 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRATINE FOREHEAD COAPT SYSTEMS, INC. 510(k) NO: K060249(TRADITIONAL)
ATTN: LINDA RUEDY PHONE NO : 650-461-7647 1820 EMBARCADERO RD. SE DECISION MADE: 12-JUN-06 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOMMANDER PLUS COLLABORATIVEMED, LLC 510(k) NO: K061110(TRADITIONAL)
ATTN: ROBERT BOOTH PHONE NO : 864-370-3297 14-D PELHAM RIDGE DRIVE SE DECISION MADE: 07-JUN-06 GREENVILLE, SC 29615 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURAB COLLAGEN MATRIX, INC. 510(k) NO: K061487(SPECIAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477 509 COMMERCE ST. SE DECISION MADE: 26-JUN-06 FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPIVISION DIGITAL IMAGING SYSTEM COMMUNICATIONS & POWER INDUSTRIES 510(k) NO: K061173(TRADITIONAL)
ATTN: NORM MORIKAWA PHONE NO : 905 877 0161 45 RIVER DRIVE SE DECISION MADE: 09-JUN-06 GEORGETOWN,ONTARIO, CANADA L7G 2J4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 CONFLUENT SURGICAL,INC 510(k) NO: K061183(SPECIAL)
ATTN: ERIC P ANKERUD PHONE NO : 781-693-2333 101A FIRST AVE. SE DECISION MADE: 01-JUN-06 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERVICE MANAGER SM40SE CONMED INTEGRATED SYSTEMS, CANADA,510(k) NO: K053464(TRADITIONAL)
ATTN: MICHAEL T TAGGART PHONE NO : 727-399-5334 11311 CONCEPT BLVD SE DECISION MADE: 06-JUN-06 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIPI CONTIPI LTD. 510(k) NO: K060526(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW COURT SE DECISION MADE: 09-JUN-06 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOHYSTEROGRAPHY BIOPSY DEVICE COOK UROLOGICAL, INC. 510(k) NO: K060908(TRADITIONAL)
ATTN: CINDY RUMPLE PHONE NO : 812-829-4891 1100 WEST MORGAN ST. SE DECISION MADE: 29-JUN-06 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT COPAN DIAGNOSTICS, INC. 510(k) NO: K061301(TRADITIONAL)
ATTN: CYNTHIA SINCLAIR PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 23-JUN-06 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTICOVER SKIN BARRIER DEVICE D & D HOLDINGS, LLC 510(k) NO: K042955(TRADITIONAL)
ATTN: MARK CITRON PHONE NO : 615-481-8198 10 WYNSTONE SE DECISION MADE: 19-JUN-06 NASHVILLE, TN 37215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 DADE BEHRING, INC. 510(k) NO: K061218(TRADITIONAL) ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376 P.O. BOX 6101 SE DECISION MADE: 30-JUN-06 NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) DADE BEHRING, INC. 510(k) NO: K061503(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 302-631-9454 P.O. BOX 6101 MS 514 SE DECISION MADE: 22-JUN-06 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAN MONOPOLAR LAP ACCESSORIES DANNORITZER MEDIZINTECHNIK GMBH & 510(k) NO: K052759(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : +31 204 289591 AMSTEL-320-I SE DECISION MADE: 14-JUN-06 AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. 510(k) NO: K060862(TRADITIONAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 05-JUN-06 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC. 510(k) NO: K061609(SPECIAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 27-JUN-06 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH DAVOL INC., SUB. C.R. BARD, INC. 510(k) NO: K061314(TRADITIONAL)
ATTN: ROBIN N DRAGO PHONE NO : 401-463-7000 100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 02-JUN-06 CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 DELTA ENTERPRISE CORPORATION 510(k) NO: K052513(TRADITIONAL)
ATTN: MARIA E CELIS PHONE NO : 212-635-2730 17 STATE STREET, 19TH FLOOR SE DECISION MADE: 28-JUN-06 NEW YORK, NY 10004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDY ORTHODONTIC SCREW DENTIUM CO., LTD. 510(k) NO: K060500(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909 5536 TROWBRIDGE DRIVE SE DECISION MADE: 16-JUN-06 DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPLANTIUM II DENTIUM CO., LTD. 510(k) NO: K060501(ABBREVIATED)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909 5536 TROWBRIDGE DRIVE SE DECISION MADE: 16-JUN-06 DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-IMPRESSION CONDITIONING SOLUTION DENTSPLY INTL. 510(k) NO: K061427(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 26-JUN-06 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: FASTIN RC ANCHOR DEPUY MITEK 510(k) NO: K060664(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988 325 PARAMOUNT DRIVE SE DECISION MADE: 06-JUN-06 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILAGRO INTERFERENCE SCREW DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K060830(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988 325 PARAMOUNT DR. SE DECISION MADE: 15-JUN-06 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY GLOBAL AP SHOULDER SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060874(TRADITIONAL)
ATTN: NATALIE S HECK PHONE NO : 574-372-7469 700 ORTHOPAEDIC DR. SE DECISION MADE: 28-JUN-06 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. 510(k) NO: K061144(TRADITIONAL)
ATTN: NATALIE S HECK PHONE NO : 574-267-8143 700 ORTHOPAEDIC DR. SE DECISION MADE: 08-JUN-06 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: VIPER SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K061520(SPECIAL)
ATTN: MARY GRAY PHONE NO : 508-828-3649 325 PARAMOUNT DR. SE DECISION MADE: 23-JUN-06 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMATECH IV HOLDER DERMATECH MEDICAL INC 510(k) NO: K060488(TRADITIONAL)
ATTN: GLENN THIBAULT PHONE NO : 303-596-1108 102 HERITAGE AVE SE DECISION MADE: 08-JUN-06 CASTLE ROCK, CO 80104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFE TIP SYRINGE DEVON SAFETY PRODUCTS, INC. 510(k) NO: K060668(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 PO BOX 560 SE DECISION MADE: 12-JUN-06 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND H DIAZYME LABORATORIES 510(k) NO: K061296(SPECIAL)
ATTN: ROLAND STRICKLAND PHONE NO : 858-455-4761 3550 GENERAL ATOMICS CT. SE DECISION MADE: 13-JUN-06 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: CONFIDENCE HIGH VISCOSITY BONE CEMENT DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K060300(TRADITIONAL)
ATTN: HILA WACHSLER-AVRAHAMI PHONE NO : 972 9 9511511 11 HA'HOSHLIM ST. SE DECISION MADE: 21-JUN-06 HERZLIYA, ISRAEL 46724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K060876(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074 9115 HAGUE ROAD SE DECISION MADE: 15-JUN-06 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE S DOLPHIN MEDICAL INC. 510(k) NO: K060524(SPECIAL)
ATTN: BILL CURNAN PHONE NO : 720-348-0389 9433 S. MORNING GLORY LN. SE DECISION MADE: 15-JUN-06 HIGHLANDS RANCH, CO 80130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) DR. HOWARD MARTIN, P.A. 510(k) NO: K051573(TRADITIONAL)
ATTN: KYLE H SIBINOVIC PHONE NO : 301-695-1200 4327 REELS MILL RD. SE DECISION MADE: 26-JUN-06 FREDERICK, MD 21704 510(k) STATEMENT DEVICE: CARINA HOME DRAEGER MEDICAL B.V. 510(k) NO: K060705(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215-721-5400 3135 QUARRY ROAD SE DECISION MADE: 14-JUN-06 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT DREW SCIENTIFIC LTD. 510(k) NO: K060510(TRADITIONAL)
ATTN: DIANE HILL PHONE NO : 441 229 432089 SOWERBY WOODS BUSINESS PARK SE DECISION MADE: 19-JUN-06 PARK ROAD 510(k) STATEMENT BARROW IN FURNESS CUMBRIA, UNITED KINGDOM LA14 4QR DEVICE: DUTECK BODY COMPOSITION ANALYZER DUTECK INDUSTRIAL CO., LTD. 510(k) NO: K060642(TRADITIONAL)
ATTN: JOSEPH CHEN PHONE NO : 886 287 975035 3F-2, NO. 26, 513 LANE SE DECISION MADE: 07-JUN-06 JUI-KUANG ROAD 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) 114 DEVICE: DYNATRON ION IONTOPHORESIS ELECTRODE DYNATRONICS CORP. 510(k) NO: K060814(TRADITIONAL)
ATTN: KELVYN CULLIMORE, JR PHONE NO : 801-874-6251 7030 PARK CENTRE DR. SE DECISION MADE: 14-JUN-06 SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) E-SAN LIMITED 510(k) NO: K061328(TRADITIONAL)
ATTN: KRISTIN M ZIELINSKI PHONE NO : 202-822-1853 2001 PENNSYLVANIA AVE. NW. SE DECISION MADE: 13-JUN-06 STE 575 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: EBI ESL PEEK-OPTIMA SPINE SYSTEM EBI, L.P. 510(k) NO: K061016(SPECIAL)
ATTN: JENNIFER HARAKAL PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 08-JUN-06 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI ARRAY SPINAL SYSTEM EBI, L.P. 510(k) NO: K061563(SPECIAL)
ATTN: JENNIFER P HARAKAL PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 23-JUN-06 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MUCOGRAFT ED. GEISTLICH SOEHNE AG FUER CHEMI510(k) NO: K061244(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-772-5333 1300 I STREET, N.W. SE DECISION MADE: 06-JUN-06 11TH FLOOR EAST 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: QUIX DIGITAL RADIOGRAPHIC UPGRADE EDGE MEDICAL DEVICES LTD. 510(k) NO: K052661(TRADITIONAL)
ATTN: VERED SCHARF PHONE NO : 972 974 13675 25 HATASIYA SE DECISION MADE: 07-JUN-06 RAANANA, ISRAEL 43654 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTENT TURBO BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. 510(k) NO: K061235(SPECIAL)
ATTN: KEVIN DRISKO PHONE NO : 949-250-2500 ONE EDWARDS WAY SE DECISION MADE: 05-JUN-06 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Y-CLICK CONNECTOR ELCAM MEDICAL ACAL 510(k) NO: K060759(TRADITIONAL)
ATTN: TALI HAZAN PHONE NO : KIBUTZ BARAM SE DECISION MADE: 29-JUN-06 D.N. MEROM HAGALIL, ISRAEL 13860 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGI-MAX ELLMAN INT'L INC. 510(k) NO: K061174(TRADITIONAL)
ATTN: JON GARITO PHONE NO : 516-267-6502 3333 ROYAL AVENUE SE DECISION MADE: 28-JUN-06 OCEANSIDE, NY 11572-3625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMJOI TENS DEVICE EMJOI, INC. 510(k) NO: K052711(TRADITIONAL)
ATTN: MIKE JUDGE PHONE NO : 804-253-7274 2943 OAK LAKE BLVD. SE DECISION MADE: 23-JUN-06 MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENDIUS ATAVI SYSTEM ENDIUS, INC. 510(k) NO: K061345(SPECIAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 06-JUN-06 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MO ENGINIVITY LLC 510(k) NO: K060537(TRADITIONAL)
ATTN: PENELOPE GRECO PHONE NO : 508-843-0282 8 GRAY LODGE ROAD SE DECISION MADE: 08-JUN-06 KITTERY, ME 03904 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIDERX EMBOLIC PROTECTION DEVICE EV3 INC. 510(k) NO: K053195(TRADITIONAL)
ATTN: BRENDA JOHNSON PHONE NO : 763-398-7238 4600 NATHAN LN. NORTH SE DECISION MADE: 23-JUN-06 PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNAP II EEG MONITOR EVEREST BIOMEDICAL INSTRUMENTS CO.510(k) NO: K060997(TRADITIONAL)
ATTN: RANDALL J KROHN PHONE NO : 636-519-7770 16690 SWINGLEY RIDGE RD. SE DECISION MADE: 15-JUN-06 SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA CHESTERFIELD, MO 63017 DEVICE: EXACTECH EQUINOXE SHOULDER STEMS EXACTECH, INC. 510(k) NO: K061454(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 12-JUN-06 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS FRESENIUS KABI DEUTSCHLAND GMBH 510(k) NO: K060316(TRADITIONAL)
ATTN: BARBARA BREUER-THAL PHONE NO : 490 617 26867785 DAIMLERSTRASSE 22 SE DECISION MADE: 23-JUN-06 BAD HOMBURG, GERMANY D-61352 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K061672(TRADITIONAL)
ATTN: DEBBIE PEACOCK PHONE NO : 203-602-3775 419 WEST AVENUE SE DECISION MADE: 29-JUN-06 STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FULLCARD ANALYSIS GE HEALTHCARE 510(k) NO: K061587(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 23-JUN-06 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AUTOBONE2 GE HEALTHCARE 510(k) NO: K061625(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 26-JUN-06 MAILSTOP W-440 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 THIRD PARTY REVIEW DEVICE: PRECISION THUNIS 800+ GE MEDICAL SYSTEMS, LLC 510(k) NO: K061028(ABBREVIATED)
ATTN: LARRY KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 07-JUN-06 W-440 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 DEVICE: INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA GE MEDICAL SYSTEMS, LLC 510(k) NO: K061163(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 07-JUN-06 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 GENERAL ELECTRIC CO. 510(k) NO: K061129(SPECIAL)
ATTN: PATRICIA TAIGE PHONE NO : 414-721-3222 99000 INNOVATION DRIVE SE DECISION MADE: 01-JUN-06 WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANQUIL TRI-BTE GENERAL HEARING INSTRUMENTS, INC. 510(k) NO: K061459(SPECIAL)
ATTN: ROGER P JUNEAU PHONE NO : 504-733-3767 P.O. BOX 23748 SE DECISION MADE: 30-JUN-06 NEW ORLEANS, LA 70183-0748 510(k) STATEMENT DEVICE: OSOM INFLUENZA A&B TEST GENZYME CORP. 510(k) NO: K061508(TRADITIONAL)
ATTN: FRED D LASKY PHONE NO : 617-591-5512 ONE KENDALL SQUARE SE DECISION MADE: 12-JUN-06 CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETAIN RADIOLUCENT SPACER GLOBUS MEDICAL, INC. 510(k) NO: K061380(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 303 SCHELL LANE SE DECISION MADE: 08-JUN-06 PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS GOOD MEDY ENTERPRISE LTD. 510(k) NO: K061007(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 229 044502 1 F., NO. 72, ALLEY 33 SE DECISION MADE: 14-JUN-06 LANE 514, JONGIENG ROAD 510(k) SUMMARY AVAILABLE FROM FDA SHINGJUANG CITY, TAIPEI, CHINA (TAIWAN) 24255 DEVICE: PARTIAL OSSICULAR REPLACEMENT PROSTHESES GRACE MEDICAL, INC. 510(k) NO: K060518(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-380-7000 8500 WOLF LAKE DR., STE. 110 SE DECISION MADE: 28-JUN-06 MEMPHIS, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-TORQUE WHISPER VIEW GUIDE WIRE GUIDANT CORP. 510(k) NO: K061453(SPECIAL)
ATTN: KATHLEEN VITTUM PHONE NO : 651-582-4820 4100 HAMLINE AVE., NORTH SE DECISION MADE: 22-JUN-06 ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNILINK. 018 BILIARY STENT SYSTEM GUIDANT ENDOVASCULAR SOLUTIONS, IN510(k) NO: K060817(TRADITIONAL) ATTN: MARA CALER PHONE NO : 951-914-2008 3200 LAKESIDE DR. SE DECISION MADE: 15-JUN-06 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MO GVS SPA 510(k) NO: K061115(ABBREVIATED)
ATTN: DAWN I MOORE PHONE NO : 734-428-8988 20171 BOWENS RD SE DECISION MADE: 30-JUN-06 MANCHESTER, MI 48158-9600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE POWDER FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD 510(k) NO: K052583(TRADITIONAL)
ATTN: KUAN KAM HON PHONE NO : 603 627 42177 9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 14-JUN-06 KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 52100 DEVICE: GLUCOPACK HEALTHPIA AMERICA CORP. 510(k) NO: K052469(TRADITIONAL)
ATTN: STEVEN KIM PHONE NO : 973-286-7676 211 WARREN STREET SE DECISION MADE: 05-JUN-06 NEWARK, NJ 07103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 1 HEMOCUE AB 510(k) NO: K061047(TRADITIONAL)
ATTN: ALLAN WHITE PHONE NO : 949-859-2630 40 EMPIRE DRIVE SE DECISION MADE: 08-JUN-06 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATEX POWDERED EXAMINATION GLOVE HIGH MOMENTUM SDN BHD 510(k) NO: K060858(TRADITIONAL)
ATTN: HUE K FAH PHONE NO : 033 392 3375 LOT 4960, JALAN TERATAI BATU 6 SE DECISION MADE: 08-JUN-06 OFF JALAN MERU 510(k) SUMMARY AVAILABLE FROM FDA KLANG, SELANGOR DARUL ESHSAN, MALAYSIA 41050 DEVICE: GENESIS OTC MONITOR HONEYWELL HOMMED, LLC 510(k) NO: K061087(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111 2018 NORTH DURHAM DRIVE SE DECISION MADE: 09-JUN-06 HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTRY OTC MONITOR HONEYWELL HOMMED, LLC 510(k) NO: K061088(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111 2018 NORTH DURHAM DRIVE SE DECISION MADE: 09-JUN-06 HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WI HOSPIRA, INC. 510(k) NO: K061159(TRADITIONAL)
ATTN: THOMAS KOZMA PHONE NO : 224-212-4803 275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 26-JUN-06 D-389 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, IL 60045-5045 THIRD PARTY REVIEW DEVICE: IKOENGELO IKOETECH, LLC. 510(k) NO: K061006(TRADITIONAL)
ATTN: HUIMIN CHAO PHONE NO : 713-600-2410 3000 RICHMOND, SUITE 200 SE DECISION MADE: 05-JUN-06 HOUSTON, TX 77098 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMA SCREEN SPECIFIC IFOBT IMMUNOSTICS, INC. 510(k) NO: K060463(TRADITIONAL)
ATTN: JEFFREY FLEISHMAN PHONE NO : 732-918-0770 3505 SUNSET AVE. SE DECISION MADE: 06-JUN-06 OCEAN, NJ 07712 510(k) STATEMENT DEVICE: DEPOTONE IMPRINT PHARMACEUTICALS LIMITED 510(k) NO: K061032(SPECIAL)
ATTN: MERVYN LITTLE PHONE NO : 44 208 2249958 53 LANGTON ROAD SE DECISION MADE: 21-JUN-06 EAST MOLESEY, SURREY, UNITED KINGD510(k) STATEMENT DEVICE: INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 INFRAREDX, INC. 510(k) NO: K052908(TRADITIONAL)
ATTN: NANDINI MURTHY PHONE NO : 781-221-0053 34 THIRD AVE SE DECISION MADE: 23-JUN-06 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTERYX ANTERIOR CERVICAL PLATE SYSTEM INNOVASIS, INC. 510(k) NO: K061147(TRADITIONAL)
ATTN: DAVID N MCKEAN PHONE NO : 801-261-2236 614 EAST 3900 SOUTH SE DECISION MADE: 30-JUN-06 SALT LAKE CITY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSIGHT HEAD COIL INSIGHT NEUROIMAGING SYSTEMS LLC 510(k) NO: K061281(TRADITIONAL)
ATTN: PATRICIA A MILBANK PHONE NO : 425-894-9733 11 CANTERBURY STREET SE DECISION MADE: 19-JUN-06 WORCHESTER, MA 01610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART USBLITE, MODEL M011120 INTELLIGENT HEARING SYSTEMS 510(k) NO: K061443(SPECIAL)
ATTN: EDWARD MISKIEL PHONE NO : 305-668-6102 6860 S.W. 81ST ST. SE DECISION MADE: 23-JUN-06 MIAMI, FL 33143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILOT TEST OR DETECTIVE AUDIOMETERS INTERACOUSTICS A/S 510(k) NO: K060883(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-903-4157 7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 23-JUN-06 EDEN PRAIRIE, MN 55344 510(k) STATEMENT DEVICE: MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROG INTERLAB S.R.L. 510(k) NO: K053571(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198 150 CHERRY LANE ROAD SE DECISION MADE: 30-JUN-06 EAST STROUDSBURG, PA 18301 510(k) STATEMENT DEVICE: ICHEM 100 URINE CHEMISTRY ANALYZER IRIS INTERNATIONAL, INC. 510(k) NO: K060280(TRADITIONAL)
ATTN: GERALD J HADDOCK PHONE NO : 818-709-1244 9172 ETON AVE. SE DECISION MADE: 13-JUN-06 CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C ISOVAC PRODUCTS LLC 510(k) NO: K052798(TRADITIONAL)
ATTN: LISA S JONES PHONE NO : 713-664-6775 540 COLLEGE ST SE DECISION MADE: 06-JUN-06 BELLAIRE, TX 77401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILKLINE SOFT RELINING KIT, MODEL 28-100100 J. MORITA USA, INC. 510(k) NO: K060844(TRADITIONAL)
ATTN: HOWARD ROWE PHONE NO : 949-465-1034 9 MASON SE DECISION MADE: 06-JUN-06 IRVINE, CA 92618 510(k) STATEMENT DEVICE: PORCELAIN PRIMER J. MORITA USA, INC. 510(k) NO: K061322(TRADITIONAL)
ATTN: HOWARD ROWE PHONE NO : 949-465-1034 9 MASON SE DECISION MADE: 02-JUN-06 IRVINE, CA 92618 510(k) STATEMENT DEVICE: POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLOR JIANGSU EVERYGUARD PLASTIC PRODUCT510(k) NO: K060910(TRADITIONAL)
ATTN: CHU XIA OAN PHONE NO : 861 082 387441 RM 1606 BLDG 1JIANZIANG YUAN SE DECISION MADE: 07-JUN-06 NO 209 BEI SI HUAN SHONG RD HA 510(k) STATEMENT BEIJING, CHINA DEVICE: TRIDENT ANCHOR JOHNSON & JOHNSON COMPANY 510(k) NO: K060914(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988 325 PARAMOUNT DRIVE SE DECISION MADE: 09-JUN-06 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-SHIELD PORT ACCESS INFUSION SET KAWASUMI LABORATORIES, INC. 510(k) NO: K060580(TRADITIONAL)
ATTN: JACK PAVLO PHONE NO : 813-830-5554 4723 OAK FAIR BLVD SE DECISION MADE: 06-JUN-06 TAMPA, FL 33610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER KAWASUMI LABORATORIES, INC. 510(k) NO: K061197(TRADITIONAL)
ATTN: SUZAN ONEL PHONE NO : 202-778-9134 1601 K STREET, N.W. SE DECISION MADE: 30-JUN-06 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERCH ARCH BAR, MODEL 38-690-00 KLS-MARTIN L.P. 510(k) NO: K061271(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746 11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 30-JUN-06 SOUTH 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32246 DEVICE: SIGMA 5000 SERIES, IMAGIC KONTRON MEDICAL SYSTEMS SAS 510(k) NO: K061437(TRADITIONAL)
ATTN: LARRY WALKER PHONE NO : 800-365-6668 17725 N.E. 65TH STREET SE DECISION MADE: 14-JUN-06 BLDG. C 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98052-4911 THIRD PARTY REVIEW DEVICE: KOWA KT-800 KOWA CO. LTD. 510(k) NO: K053444(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 81 596 370190 319 AKENO SE DECISION MADE: 09-JUN-06 OBATA-CHO, WATARAI-GUN 510(k) SUMMARY AVAILABLE FROM FDA MIE-KEN, JAPAN 519-05 DEVICE: FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL KYPHON, INC. 510(k) NO: K061210(SPECIAL)
ATTN: CINDY DOMECUS PHONE NO : 408-548-5421 1221 CROSSMAN AVE. SE DECISION MADE: 27-JUN-06 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 KYRON CLINICAL IMAGING, INC. 510(k) NO: K061255(TRADITIONAL)
ATTN: JAMES L REUSS PHONE NO : 414-727-1930 2457 N. MAYFAIR RD., SUITE 202 SE DECISION MADE: 13-JUN-06 WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIB LAB VISION CORP. 510(k) NO: K061360(TRADITIONAL)
ATTN: GRACE HSIAO-FEN CHANG PHONE NO : 510-991-2854 47777 WARM SPRINGS BLVD. SE DECISION MADE: 27-JUN-06 FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCE LASERSCOPE 510(k) NO: K061646(TRADITIONAL)
ATTN: PAUL HARDIMAN PHONE NO : 800-243-9384 3070 ORCHARD DR. SE DECISION MADE: 27-JUN-06 SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AFIBALERT ATRIAL FIBRILLATION DETECTOR LECHNOLOGIES RESEARCH INC. 510(k) NO: K052767(TRADITIONAL)
ATTN: STEPHANIE KING PHONE NO : 763-287-3830 4050 OLSEN MEMORIAL HIGHWAY SE DECISION MADE: 23-JUN-06 MINNEAPOLIS, MN 55422 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POINTER PLUS LHASA OMS, INC. 510(k) NO: K060508(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1071 230 LIBBEY PKWY. SE DECISION MADE: 19-JUN-06 WEYMOUTH, MA 02189 510(k) STATEMENT DEVICE: POINTER EXCEL LHASA OMS, INC. 510(k) NO: K060517(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1072 230 LIBBEY PKWY. SE DECISION MADE: 19-JUN-06 WEYMOUTH, MA 02189 510(k) STATEMENT DEVICE: IR PRO 250 LHASA OMS, INC. 510(k) NO: K061080(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1072 230 LIBBEY PKWY. SE DECISION MADE: 14-JUN-06 WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOD POD LIFE MEASUREMENT, INC. 510(k) NO: K060848(ABBREVIATED)
ATTN: MICHAEL SULLIVAN PHONE NO : 925-676-6002 1850 BATES AVE. SE DECISION MADE: 27-JUN-06 CONCORD, CA 94520-8586 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES LUCENT MEDICAL SYSTEMS 510(k) NO: K061240(SPECIAL)
ATTN: CYNTHIA PESTKA PHONE NO : 425-822-3310 811 KIRKLAND AVENUE; SUITE 100 SE DECISION MADE: 02-JUN-06 KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LBI CATHETER SYSTEM LUMEN BIOMEDICAL, INC. 510(k) NO: K053372(TRADITIONAL)
ATTN: AMY PETERSON PHONE NO : 763-577-9600 2605 FERNBROOK LANE SE DECISION MADE: 30-JUN-06 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 DEVICE: MODEL MI 44 TYMPANOMETER MAICO-DIAGNOSTICS 510(k) NO: K060885(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-278-4457 7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 05-JUN-06 EDEN PRAIRIE, MN 55344 510(k) STATEMENT DEVICE: QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 MAQUET CARDIOPULMONARY AG 510(k) NO: K061546(SPECIAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 49 747 89210 HECHINGER STRASSE 38 SE DECISION MADE: 20-JUN-06 HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LNCS AND SPO2.COM SENSORS MASIMO CORPORATION 510(k) NO: K060143(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7218 40 PARKER SE DECISION MADE: 16-JUN-06 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 MBL INTERNATIONAL CORPORATION 510(k) NO: K060431(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 19-JUN-06 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOTOOL DRUG DOSE CALCULATOR MD SCIENTIFIC LLC 510(k) NO: K053137(TRADITIONAL)
ATTN: SHADE M MECUM PHONE NO : 704-335-1300 1214 WAREHAM COURT SE DECISION MADE: 14-JUN-06 CHARLOTTE, NC 28207 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AG-PLUS, MODEL 91210 MEDEL S.P.A. 510(k) NO: K060404(ABBREVIATED)
ATTN: TERRENCE O'BRIEN PHONE NO : 919-468-9552 112 CAVISTON WAY SE DECISION MADE: 22-JUN-06 CARY, NC 27519 510(k) STATEMENT DEVICE: MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR MEDELA AG 510(k) NO: K061205(TRADITIONAL)
ATTN: WERNER FREI PHONE NO : 041 769 5151 LAETTICHSTRASSE 4B SE DECISION MADE: 21-JUN-06 BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDELA VARIO 8 AND 18 SUCTION PUMPS MEDELA AG 510(k) NO: K061435(TRADITIONAL)
ATTN: WERNER FREI PHONE NO : 041 769 5151 LAETTICHSTRASSE 4B SE DECISION MADE: 08-JUN-06 BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MEDI-GLOBE ROTA-CUT SPHINCTEROTOME MEDI-GLOBE CORPORATION 510(k) NO: K061684(TRADITIONAL)
ATTN: SCOTT KARLER PHONE NO : 480-897-2772 110 WEST ORION #136 SE DECISION MADE: 27-JUN-06 TEMPE, AZ 85248 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LUNG FLUTE MEDICAL ACOUSTICS LLC 510(k) NO: K060439(TRADITIONAL)
ATTN: NICOLAAS J SMIT PHONE NO : 905-931-2311 255 GREAT ARROW AVE., SE DECISION MADE: 22-JUN-06 SUITE 23 510(k) SUMMARY AVAILABLE FROM FDA BUFFALO, NY 14207 DEVICE: DEFIBRILLATOR CABLE TESTER, MODEL DT2200 MEDICAL DEVICES/PADPRO, INC. 510(k) NO: K061606(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 21-JUN-06 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COOL.CLICK 2 MEDICAL HOUSE PRODUCTS LIMITED 510(k) NO: K060819(TRADITIONAL)
ATTN: ROSE Y GUANG PHONE NO : 44 114 2619011 199 NEWHALL ROAD SE DECISION MADE: 16-JUN-06 SHEFFIELD, UNITED KINGDOM S9 2QJ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE COLLAGEN WOUND DRESSING MEDLINE INDUSTRIES, INC. 510(k) NO: K060456(ABBREVIATED)
ATTN: LARA N SIMMONS PHONE NO : 847-837-2759 ONE MEDLINE PL. SE DECISION MADE: 19-JUN-06 MUNDELEIN, IL 60060 510(k) STATEMENT DEVICE: MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PR MEDTRADE PRODUCTS LTD. 510(k) NO: K061079(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019 ELECTRA HOUSE SE DECISION MADE: 02-JUN-06 CREWE BUSINESS PARK 510(k) STATEMENT CREWE, CHESHIRE, UNITED KINGDOM CW1 6GL DEVICE: EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K061254(SPECIAL)
ATTN: RONALD W BENNETT PHONE NO : 763-391-9083 7611 NORTHLAND DR. SE DECISION MADE: 23-JUN-06 MINNEAPOLIS, MN 55038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXA MERETE MEDICAL GMBH 510(k) NO: K051965(TRADITIONAL)
ATTN: CARL KNOBLOCH PHONE NO : 407-977-8609 5349 RED LEAF COURT SE DECISION MADE: 16-JUN-06 OVIEDO, FL 32765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K060686(SPECIAL)
ATTN: ARIEL WANG PHONE NO : 886 287 971288 MAX SCHMIDHEINY-STRASSE 201 SE DECISION MADE: 09-JUN-06 HEERBRUGG, SWITZERLAND 9435 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K061403(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 14-JUN-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K061558(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 29-JUN-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL PRINTER P6000D SERIES, MODEL P6000DU MITSUBISHI ELECTRIC CORPORATION KY510(k) NO: K061302(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 815 963 70190 319 AKENO, OBATA-CHO SE DECISION MADE: 23-JUN-06 ISE-SHI, JAPAN MIE-KEN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-USE ELECTRONIC PREGNANCY TEST MIZUHO USA, INC. 510(k) NO: K060825(TRADITIONAL)
ATTN: BENEDICT ZIN PHONE NO : 858-679-0555 12131 COMMUNITY RD. SE DECISION MADE: 19-JUN-06 POWAY, CA 92064 510(k) STATEMENT DEVICE: NANOLITE SKIN CARE SYSTEM NANOLITE TECHNOLOGY, INC. 510(k) NO: K061117(ABBREVIATED)
ATTN: EDWIN BURGOS PHONE NO : 310-792-7070 21250 HAWTHORNE BLVD. SE DECISION MADE: 20-JUN-06 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA TORRANCE, CA 90503 THIRD PARTY REVIEW DEVICE: V-2200 INFANT INCUBATOR NEOFORCE GROUP, INC. 510(k) NO: K061280(TRADITIONAL)
ATTN: MARY STANIEWICZ PHONE NO : 215-672-6800 5985 HONEY HOLLOW RD. SE DECISION MADE: 27-JUN-06 DOYLESTOWN, PA 18901 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SFB & CFB IMPLANTS NOBEL BIOCARE AB 510(k) NO: K061003(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074 22715 SAVI RANCH PARKWAY SE DECISION MADE: 30-JUN-06 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSSEOUS DENTAL IMPLANT NORTHERN IMPLANTS, LLC 510(k) NO: K061169(TRADITIONAL)
ATTN: GRETA M HOLS PHONE NO : 703-278-3953 10355 B DEMOCRACY LANE SE DECISION MADE: 20-JUN-06 FAIRFAX, VA 22030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) O'BRIEN DENTAL LAB, INC. 510(k) NO: K060744(ABBREVIATED)
ATTN: SUZIE DOWNING PHONE NO : 541-754-1238 4311 SW RESEARCH WAY SE DECISION MADE: 02-JUN-06 CORVALLIS, OR 97333 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH M OLYMPUS AMERICA INC. 510(k) NO: K060201(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 972-556-9697 3131 W. ROYAL LANE SE DECISION MADE: 06-JUN-06 IRVING, TX 75063-3104 510(k) STATEMENT DEVICE: OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K060243(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 23-JUN-06 MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX KNEE SYSTEM OMNI LIFE SCIENCE, INC. 510(k) NO: K060192(TRADITIONAL)
ATTN: EDWARD J CHEAL PHONE NO : 760-734-1577 175 PARAMOUNT DRIVE SE DECISION MADE: 15-JUN-06 SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA RAYNHAM, MA 02767 DEVICE: PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 OMRON HEALTHCARE, INC. 510(k) NO: K060766(TRADITIONAL)
ATTN: DONNA DJINOVICH PHONE NO : 847-247-5713 1200 LAKESIDE DRIVE SE DECISION MADE: 09-JUN-06 BANNOCKBURN, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRA ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K060632(TRADITIONAL)
ATTN: LEAH DE WATER PHONE NO : 585-453-4131 100 INDIGO CREEK DR. SE DECISION MADE: 06-JUN-06 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR K ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K061464(SPECIAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253 100 INDIGO CREEK DR. SE DECISION MADE: 15-JUN-06 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCANEAL TRAUMA SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K061400(TRADITIONAL)
ATTN: LEE A STRNAD PHONE NO : 330-869-9563 1815 WEST MARKET ST. SE DECISION MADE: 29-JUN-06 SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA AKRON, OH 44313 DEVICE: OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM OSTEOMED L.P. 510(k) NO: K060536(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-677-4600 3885 ARAPAHO RD. SE DECISION MADE: 02-JUN-06 ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) OWANDY SAS 510(k) NO: K053172(TRADITIONAL)
ATTN: OLIVIER MAURIER PHONE NO : 164-111-818 1251 AVENUE OF THE AMERICAS SE DECISION MADE: 09-JUN-06 34TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10020 DEVICE: EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV PAJUNK GMBH 510(k) NO: K060563(TRADITIONAL)
ATTN: CHRISTAIN QUASS PHONE NO : 049 770 49291533 KARL-HALL-STRASSE 1 SE DECISION MADE: 02-JUN-06 GEISINGEN, GERMANY D-78187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPILONG KIT FOR ANESTHESIOLOGY PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K060311(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 049 770 49192533 KARL-HALL-STRASSE 1 SE DECISION MADE: 13-JUN-06 GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LC STAR WITH NASAL ADAPTER PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K061381(TRADITIONAL)
ATTN: MICHAEL JUDGE PHONE NO : 804-253-7274 2943 OAKLAKE BLVD. SE DECISION MADE: 02-JUN-06 MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CZ-S2000 PARKELL, INC. 510(k) NO: K060946(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134 300 EXECUTIVE DR. SE DECISION MADE: 15-JUN-06 EDGEWOOD, NY 11717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTROTILT MANUAL WHEELCHAIR PDG PRODUCT DESIGN GROUP, INC. 510(k) NO: K061475(TRADITIONAL)
ATTN: NANCY BALCOM PHONE NO : 604 323 9220 UNIT 102-366 E. KENT AVE. SE DECISION MADE: 14-JUN-06 SOUTH 510(k) STATEMENT VANCOUVER, BC, CANADA V5X 4N6 THIRD PARTY REVIEW DEVICE: PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 PEREGRINE SURGICAL LTD. 510(k) NO: K061024(TRADITIONAL)
ATTN: TODD RICHMOND PHONE NO : 215-348-0456 51 BRITAIN DR. SE DECISION MADE: 21-JUN-06 NEW BRITAIN, PA 18901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFIDOSE IM AUTO-INJECTOR PHARMA-PEN, INC. 510(k) NO: K060389(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794 555 13TH STREET, NW SE DECISION MADE: 06-JUN-06 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPO PHD MEDICAL 510(k) NO: K060616(TRADITIONAL)
ATTN: NANCY RUTH PHONE NO : 905 689 3980 4 INNOVATION DRIVE SE DECISION MADE: 29-JUN-06 DUNDAS, ON, CANADA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRILLIANCE VOLUME PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K060937(TRADITIONAL)
ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528 595 MINER RD. SE DECISION MADE: 05-JUN-06 CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, POROUS MEDIA CORP. 510(k) NO: K061426(TRADITIONAL)
ATTN: DAVID RASCH PHONE NO : 651-653-2000 1350 HAMMOND RD. SE DECISION MADE: 05-JUN-06 ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O PRECISE MEDICAL PRODUCTS, LTD. 510(k) NO: K061409(SPECIAL)
ATTN: OFER SHAY PHONE NO : 972 498 09193 DORA ST. (INDUSTRIAL ZONE) SE DECISION MADE: 16-JUN-06 SHLOMI, ISRAEL 22832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVJET TURBO PROMEDIC, INC. 510(k) NO: K060842(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 WEST WATERVIEW CT. SE DECISION MADE: 21-JUN-06 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE PT MAHAKARYA INTI BUANA 510(k) NO: K053305(TRADITIONAL)
ATTN: P. SASITHARAN NAIR PHONE NO : 626 179 44880 DESA DALU 10 A DUSUN 1 NO. 18 SE DECISION MADE: 02-JUN-06 TANJUNG MORAWA - 20362 510(k) SUMMARY AVAILABLE FROM FDA SUMUT, INDONESIA, INDONESIA DEVICE: R&D LH-NRBC HEMATOLOGY CONTROL R & D SYSTEMS, INC. 510(k) NO: K061320(SPECIAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413 614 MCKINLEY PL., N.E. SE DECISION MADE: 02-JUN-06 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GERATHERM SOS-RESCUE BAG R.G. ENTERPRISES, INC. 510(k) NO: K051336(TRADITIONAL)
ATTN: RONALD G LETOUTNEAU PHONE NO : 888-750-9498 21130 BRIDGE STREET SE DECISION MADE: 29-JUN-06 SOUTHFIELD, MI 48034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPAP PLUS M-SERIES BI-LEVEL SYSTEM RESPIRONICS, INC. 510(k) NO: K061034(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 23-JUN-06 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L4 OXYGEN CONCENTRATOR RESPIRONICS, INC. 510(k) NO: K061261(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 28-JUN-06 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) RG ENT., INC. 510(k) NO: K051278(TRADITIONAL)
ATTN: RONALD G LETOURNEAU PHONE NO : 888-596-9498 21130 BRIDGE STREET SE DECISION MADE: 29-JUN-06 SOUTHFIELD, MI 48034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RITRACT SAFETY SYRINGE RITRACT LTD. 510(k) NO: K060002(TRADITIONAL)
ATTN: RUPERT NORTHCOTT PHONE NO : 61 2 89232511 201 MILLER STREET SE DECISION MADE: 02-JUN-06 LEVEL 17 510(k) SUMMARY AVAILABLE FROM FDA NORTH SYDNEY, NEW SOUTH WALES, AUSTRALIA 2060 DEVICE: ONLINE TDM TOBRAMYCIN ROCHE DIAGNOSTICS CORP. 510(k) NO: K060853(TRADITIONAL)
ATTN: DIMIRIS DEMIRTZOGLOU PHONE NO : 317-521-7688 9115 HAGUE RD. SE DECISION MADE: 09-JUN-06 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 RTC INC.-MEMCATH TECHNOLOGIES LLC 510(k) NO: K061324(TRADITIONAL)
ATTN: MARC JAKER PHONE NO : 651-450-7400 1777 OAKDALE AVE., SE DECISION MADE: 20-JUN-06 WEST ST. PAUL, MN 55118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM S.O.R. INTERNACIONAL, S.A. 510(k) NO: K052934(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 727-797-4727 SE DECISION MADE: 12-JUN-06 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPILLARY'S HEMOGLOBIN(E) (PN 2007) SEBIA 510(k) NO: K052291(TRADITIONAL)
ATTN: KAREN ANDERSON PHONE NO : 734-475-2441 13805 WATERLOO SE DECISION MADE: 27-JUN-06 CHELSEA, MI 48118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LARIAT LOOP APPLICATOR SENTREHEART 510(k) NO: K060721(TRADITIONAL)
ATTN: ROBERT CHIN PHONE NO : 650-593-5225 2468 EMBARCADERO WAY SE DECISION MADE: 02-JUN-06 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIGENT GENTAMICIN SERADYN INC. 510(k) NO: K060709(TRADITIONAL)
ATTN: EARL E KNIGHT PHONE NO : 317-554-0639 7998 GEORGETOWN RD. SE DECISION MADE: 15-JUN-06 SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46268-5260 DEVICE: CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM SHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K061488(SPECIAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1302 7263 CRONIN CIRCLE SE DECISION MADE: 30-JUN-06 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CTS-7700 SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K061083(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1302 473 SAPENA COURT SE DECISION MADE: 06-JUN-06 SUITE #26 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 94568 DEVICE: VS-800 VITAL SIGNS MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K060281(TRADITIONAL)
ATTN: SUSAN D GOLSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-JUN-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K061189(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 01-JUN-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAI-R SHL MEDICAL, USA 510(k) NO: K060141(TRADITIONAL)
ATTN: LUCIO GIAMBATTISTA PHONE NO : 973-822-3007 23 VREELAND RD., SE DECISION MADE: 12-JUN-06 SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA FLORHAM PARK, NJ 07932 DEVICE: GALILEOS IMPLANT, V 1.0 SICAT GMBH & CO. KG 510(k) NO: K061472(TRADITIONAL)
ATTN: MARKUS PARKER PHONE NO : 49 228 854697 BRUNNENALLEE 6 SE DECISION MADE: 09-JUN-06 BONN, GERMANY D-53177 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I- SICEL TECHNOLOGIES, INC. 510(k) NO: K061051(TRADITIONAL)
ATTN: TAMMY B CARREA PHONE NO : 919-465-2236 3800 GATEWAY CENTRE BLVD. SE DECISION MADE: 13-JUN-06 SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA MORRISVILLE, NC 27560 DEVICE: SYNGO TRUED, MODEL VC10A SIEMENS MEDICAL SOLUTIONS 510(k) NO: K061671(TRADITIONAL)
ATTN: JAMES E KUHN PHONE NO : 610-484-3006 20 VALLEY STREAM PARKWAY SE DECISION MADE: 29-JUN-06 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SMDIE DEVICE INTERFACING SYSTEM SIEMENS MEDICAL SOLUTIONS HEALTH S510(k) NO: K061590(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 727-797-4727 2454 MCMULLEN BOOTH ROAD SE DECISION MADE: 21-JUN-06 SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA CLEARWATER, FL 33759 THIRD PARTY REVIEW DEVICE: COHERENCE DOSIMETRIST, MODEL 2.2 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K061097(TRADITIONAL)
ATTN: KEN NEHMER PHONE NO : 925-602-8011 4040 NELSON AVE. SE DECISION MADE: 07-JUN-06 CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCENIUM 1.1 SIEMENS MOLECULAR IMAGING LTD 510(k) NO: K061545(SPECIAL)
ATTN: FRANK POKROP PHONE NO : 847-304-7516 2501 N. BARRINGTON ROAD SE DECISION MADE: 30-JUN-06 HOFFMAN ESTATES, IL 60195 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CMB ANTIMICROBIAL DRESSING SILVERLEAF MEDICAL PRODUCTS, INC. 510(k) NO: K060237(TRADITIONAL)
ATTN: DEBBIE KOENEMAN PHONE NO : 480-921-4948 1100 E UNIVERSITY DRIVE SE DECISION MADE: 15-JUN-06 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85281 DEVICE: REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING SMITH & NEPHEW, INC. 510(k) NO: K060630(ABBREVIATED)
ATTN: KATIE LOGEROT PHONE NO : 901-399-5778 1450 BROOKS RD. SE DECISION MADE: 14-JUN-06 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS SMITH & NEPHEW, INC. 510(k) NO: K061019(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 BROOKS RD. SE DECISION MADE: 06-JUN-06 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KINSA SUTURE ANCHOR SMITH & NEPHEW, INC. 510(k) NO: K061154(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036 150 MINUTEMAN RD. SE DECISION MADE: 08-JUN-06 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTRE SMITH & NEPHEW, INC. 510(k) NO: K061352(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 BROOKS RD. SE DECISION MADE: 08-JUN-06 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTEX PERCUTANEOUS TRACHEOSTOMY KIT SMITHS MEDICAL INTERNATIONAL 510(k) NO: K060945(TRADITIONAL)
ATTN: STEWART LEE PHONE NO : 44 170 6233806 1 ST. CRISPIN WAY SE DECISION MADE: 19-JUN-06 HASLINGDEN 510(k) STATEMENT ROSSENDALE, LANCASHIRE, UNITED KINGDOM BB4 4PW DEVICE: 4CIS VANE SPINE SYSTEM SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K060702(TRADITIONAL)
ATTN: SAEYOUNG AHN PHONE NO : 301-469-7912 7612 BARNUM ROAD SE DECISION MADE: 22-JUN-06 BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STOCKERT HEATER-COOLER SYSTEM 3T SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K052601(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 06-JUN-06 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STOCKERT S5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K060053(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 02-JUN-06 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR SORIN GROUP ITALIA S.R.L. 510(k) NO: K061031(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742 200 WEST STREET SE DECISION MADE: 02-JUN-06 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING SORIN GROUP ITALIA S.R.L. 510(k) NO: K061527(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742 200 WEST STREET SE DECISION MADE: 27-JUN-06 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 SPACELABS MEDICAL INC. 510(k) NO: K060900(TRADITIONAL)
ATTN: AL VAN HOUDT PHONE NO : 425-657-7200 5150 220TH AVE SE SE DECISION MADE: 23-JUN-06 PO BOX 7018 510(k) SUMMARY AVAILABLE FROM FDA ISSAQUAH, WA, WA 98027-7018 DEVICE: SSP PEDICLE SCREW SYSTEM SPECIALTY SPINE PRODUCTS, LLC 510(k) NO: K060118(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 08-JUN-06 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. SPINAL EDGE, LLC 510(k) NO: K060916(TRADITIONAL)
ATTN: CHRISTINA VACCA PHONE NO : 440-315-6973 25125 DETROIT ROAD SE DECISION MADE: 08-JUN-06 WESTLAKE, OH 44145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS SSL AMERICAS, INC. 510(k) NO: K060098(TRADITIONAL)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2152 3585 ENGINEERING DR. SE DECISION MADE: 08-JUN-06 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: SOCKET GRAFT STEINER LABORATORIES 510(k) NO: K052493(TRADITIONAL)
ATTN: GREGORY GENE STEINER PHONE NO : 949-306-9491 590 FARRINGTON HWY. SE DECISION MADE: 09-JUN-06 #524 SUITE 132 510(k) STATEMENT KAPOLEI, HI 96707 DEVICE: VASHE WOUND CLEANSING SYSTEM STERILOX TECHNOLOGIES, INC. 510(k) NO: K060901(TRADITIONAL)
ATTN: HOWARD K MANN PHONE NO : 610-341-1899 320 KING OF PRUSSIA ROAD, SE DECISION MADE: 29-JUN-06 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA RADNOR, PA 19087 DEVICE: VERIFY SYSTEM 1 BIOLOGICAL MONITORING KIT 24 HR RIT STERIS CORPORATION 510(k) NO: K060568(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207 49 PLAIN STREET SE DECISION MADE: 29-JUN-06 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 SUNTECH MEDICAL, INC. 510(k) NO: K060820(ABBREVIATED)
ATTN: DAVID GALLICK PHONE NO : 919-654-2332 507 AIRPORT BOULEVARD SE DECISION MADE: 07-JUN-06 SUITE 117 510(k) SUMMARY AVAILABLE FROM FDA MORRISVILLE, NC 27560 DEVICE: ENSEAL PTC TISSUE SEALING DEVICE SURGRX INC 510(k) NO: K061526(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-482-2400 101 SAGINAW DRIVE SE DECISION MADE: 15-JUN-06 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES SYNERGEYES, INC. 510(k) NO: K061120(ABBREVIATED)
ATTN: RICHARD E LIPPMAN, O.D. PHONE NO : 240-683-3738 15825 SHADY GROVE ROAD SE DECISION MADE: 22-JUN-06 SUITE 30 510(k) STATEMENT ROCKVILLE, MD 20850 DEVICE: SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM SYNTHES (USA) 510(k) NO: K060138(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940 1301 GOSHEN PKWY. SE DECISION MADE: 02-JUN-06 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JSZ MULTIACTION GP CONTACT LENS SOLUTION SZABOCSIK AND ASSOCIATES 510(k) NO: K060924(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828 203 NORTH WABASH AVE STE 1200 SE DECISION MADE: 28-JUN-06 CHICAGO, IL 60601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMEN TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K061073(TRADITIONAL)
ATTN: SHU-MEI WU PHONE NO : 886 266 358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 02-JUN-06 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LA TECO DIAGNOSTICS 510(k) NO: K060364(TRADITIONAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 15-JUN-06 ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMATRIX DERMAL REPAIR SCAFFOLD TEI BIOSCIENCES INC. 510(k) NO: K061407(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616 7 ELKINS ST. SE DECISION MADE: 29-JUN-06 BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGERVIEW PROFESSIONAL TELEVERE SYSTEMS 510(k) NO: K061035(TRADITIONAL)
ATTN: MELISSA MAHALL PHONE NO : 301-778-1700 6304 BELMONT CIRCLE BLDG 2 SE DECISION MADE: 05-JUN-06 MOUNT AIRY, MD 21771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAROTID ACCESS KIT TERUMO MEDICAL CORP. 510(k) NO: K060666(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 125 BLUE BALL RD. SE DECISION MADE: 29-JUN-06 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER COLLAGEN REPAIR PATCH TISSUE SCIENCE LABORATORIES, PLC 510(k) NO: K053562(TRADITIONAL)
ATTN: ANGELA BUNN PHONE NO : 678-342-7808 1141 CLARK STREET, SUITE D SE DECISION MADE: 23-JUN-06 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAG-IT CYSTIC FIBROSIS KIT TM BIOSCIENCE CORPORATION 510(k) NO: K060627(SPECIAL)
ATTN: NANCY KRUNIC PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SE DECISION MADE: 07-JUN-06 TORONTO, ONTARIO, CANADA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204) TOKOTU ELECTRIC CO., LTD. 510(k) NO: K061061(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469 300 OYA, UEDA SE DECISION MADE: 07-JUN-06 NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEMIO XG, SAA-580A TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K061605(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 22-JUN-06 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ILED TRUMPF KREUZER MEDIZIN SYSTEME GMB510(k) NO: K061317(TRADITIONAL)
ATTN: WILLIBALD HIEMER PHONE NO : 49 89 809070 BENZSTRASSE 26 SE DECISION MADE: 22-JUN-06 MUNCHEN, GERMANY 82178 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION M TWIN STAR MEDICAL 510(k) NO: K060963(TRADITIONAL)
ATTN: CHET SIEVERT PHONE NO : 612-382-0888 1000 WESTGATE DRIVE, SUITE 117 SE DECISION MADE: 06-JUN-06 ST. PAUL, MN 55114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HE TYCO HEALTHCARE GROUP 510(k) NO: K060509(TRADITIONAL)
ATTN: KEITH MARTIN PHONE NO : 508-261-8440 15 HAMPSHIRE ST. SE DECISION MADE: 23-JUN-06 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ SMART-168 GLUCOSE MONITORING SYSTEM TYSON BIORESEARCH, INC. 510(k) NO: K052818(TRADITIONAL)
ATTN: NATHAN BEAVER PHONE NO : SE DECISION MADE: 16-JUN-06 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: US SPINE FACET FIXATION SYSTEM US SPINE 510(k) NO: K061041(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999 13540 GUILD AVE SE DECISION MADE: 19-JUN-06 APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT VARIAN INC 510(k) NO: K060896(TRADITIONAL)
ATTN: LORNA GAMBOA PHONE NO : 949-770-9381 25200 COMMERCENTRE DR. SE DECISION MADE: 09-JUN-06 LAKE FOREST, CA 92630-8810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO I VENT 201 VERSAMED MEDICAL SYSTEMS, INC. 510(k) NO: K061627(SPECIAL)
ATTN: JERRY KORTEN PHONE NO : 845-770-2840 2 BLUE HILL PLAZA SE DECISION MADE: 29-JUN-06 BLDG. 2, 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA PEARL RIVER, NY 10965 DEVICE: VITREA, VERSION 3.9 VITAL IMAGES, INC. 510(k) NO: K061624(TRADITIONAL)
ATTN: TIMOTHY J KAPPERS PHONE NO : 952-487-9624 5850 OPUS PARKWAY, SE DECISION MADE: 27-JUN-06 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA MINNETONKA, MN 55343-4414 THIRD PARTY REVIEW DEVICE: VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM VOLCANO CORPORATION 510(k) NO: K060483(TRADITIONAL)
ATTN: MICHELLE J BADAL PHONE NO : 916-231-4497 2870 KILGORE RD. SE DECISION MADE: 23-JUN-06 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M-VU CAD STATION VUCOMP, INC. 510(k) NO: K061160(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD. SE DECISION MADE: 09-JUN-06 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST W.H.P.M., INC. 510(k) NO: K052197(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 09-JUN-06 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR S WALTER LORENZ SURGICAL, INC. 510(k) NO: K061384(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-9443 1520 TRADEPORT DR. SE DECISION MADE: 06-JUN-06 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOYALA, SOYALA BLUE WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K060405(TRADITIONAL) ATTN: ECKHARDT ALBERS PHONE NO : 011 494 0547020 KRONSAALSWEG 40 SE DECISION MADE: 21-JUN-06 HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE WELCH ALLYN, INC. 510(k) NO: K053381(ABBREVIATED)
ATTN: CHRIS KLACZYK PHONE NO : 315-685-3694 4341 STATE ST. RD. SE DECISION MADE: 15-JUN-06 SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AS101, BLOOD PRESSURE CUFF WENZHOU LONGWAN MEDICAL INSTRUMENT510(k) NO: K060871(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 09-JUN-06 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIEDENT ESTETIC XPDENT CORP. 510(k) NO: K061337(TRADITIONAL)
ATTN: CARMEN PEREZ PHONE NO : 305-233-3312 12145 S.W. 131ST AVE. SE DECISION MADE: 07-JUN-06 MIAMI, FL 33186 510(k) STATEMENT DEVICE: ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM ZIEHM IMAGING, INC. 510(k) NO: K061203(TRADITIONAL)
ATTN: RICHARD WESTRICH PHONE NO : 951-718-2020 4181 LATHAM ST. SE DECISION MADE: 19-JUN-06 RIVERSIDE, CA 92501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER CONTOUR RESTORATIVE SYSTEM ZIMMER DENTAL INC. 510(k) NO: K061043(TRADITIONAL)
ATTN: ERIN L MCVEY PHONE NO : 760-929-4166 1900 ASTON AVE. SE DECISION MADE: 27-JUN-06 CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES ZIMMER GMBH 510(k) NO: K061211(TRADITIONAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574-372-4570 P.O. BOX 708 SE DECISION MADE: 14-JUN-06 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 278 TOTAL WITH SUMMARIES 247 TOTAL WITH STATEMENTS 31
Updated May 2, 2007
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