SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JUN-2008 THROUGH 30-JUN-2008 DEVICE: ERGO++ VERSION 1.7 3D LINE MEDICAL SYSTEMS S.R.L. 510(k) NO: K080601(TRADITIONAL)
ATTN: THOMAS VALENTINE PHONE NO : 770-670-2548 4775 PEACHTREE INDUSTRIAL BLVD SE DECISION MADE: 06-JUN-08 BLDG 300, SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON 4M VENTURES, INC. 510(k) NO: K080703(TRADITIONAL)
ATTN: DENICE GALLAGHER PHONE NO : 972-446-6611 1415 HALSEY WAY SE DECISION MADE: 02-JUN-08 SUITE 304 510(k) SUMMARY AVAILABLE FROM FDA CARROLLTON, TX 75007-4455 DEVICE: FOXCROSS PTA CATHETER ABBOTT VASCULAR INC. 510(k) NO: K081417(SPECIAL)
ATTN: NADINE SMITH PHONE NO : 951-914-2292 3200 LAKESIDE DRIVE SE DECISION MADE: 04-JUN-08 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCIN UNIPOLAR HEAD SYSTEM ACCELERATED INNOVATION, LLC 510(k) NO: K080539(TRADITIONAL)
ATTN: MICHAEL KVITNITSKY PHONE NO : 973-777-8832 1033 US HIGHWAY 46 EAST SE DECISION MADE: 02-JUN-08 SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA CLIFTON, NJ 07013 DEVICE: CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION S ACHEVE TECHNOLOGY, INC. 510(k) NO: K072861(TRADITIONAL)
ATTN: JIM-SON CHOU PHONE NO : 949-294-6458 17100 GILLETTE AVE., UNIT 113 SE DECISION MADE: 24-JUN-08 IRVIN, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATCHHALER ACTIVAERO AMERICA, INC. 510(k) NO: K080100(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155 24301 WOODSAGE DRIVE SE DECISION MADE: 30-JUN-08 BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 ADROIT MEDICAL SYSTEMS, INC. 510(k) NO: K073712(TRADITIONAL)
ATTN: JON R HERMANSON PHONE NO : 865-458-8600 1146 CARDING MACHINE RD. SE DECISION MADE: 06-JUN-08 LOUDON, TN 37774 510(k) STATEMENT DEVICE: METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K071916(TRADITIONAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291 3773 CORPORATE PKWY. SE DECISION MADE: 02-JUN-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO AESCULIGHT, LLC 510(k) NO: K081612(TRADITIONAL)
ATTN: PAUL DIAZ PHONE NO : 425-483-8905 16928 WOOD-RED ROAD N.E. SE DECISION MADE: 25-JUN-08 SUITE B104 510(k) SUMMARY AVAILABLE FROM FDA WOODINVILLE, WA 98072 DEVICE: MACS CPAP SYSTEM AIRON CORPORATION 510(k) NO: K080692(TRADITIONAL)
ATTN: ERIC GJERDE PHONE NO : 321-821-9433 129 W. HIBISCUS BLVD., SUITE S SE DECISION MADE: 20-JUN-08 MELBOURNE, FL 32901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K072140(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158 4 HENDERSON DRIVE SE DECISION MADE: 24-JUN-08 WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S40 CLINICAL ANALYZER, S TEST IP, S TEST UA ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K072141(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158 4 HENDERSON DRIVE SE DECISION MADE: 24-JUN-08 WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K072142(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158 4 HENDERSON DRIVE SE DECISION MADE: 26-JUN-08 WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-TEST CA ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K072356(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158 4 HENDERSON DRIVE SE DECISION MADE: 24-JUN-08 WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-TEST C02 ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K073223(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158 4 HENDERSON DRIVE SE DECISION MADE: 26-JUN-08 WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-TEST CREATININE (CRE) ALFA WASSERMANN, INC. 510(k) NO: K080073(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158 4 HENDERSON DR. SE DECISION MADE: 30-JUN-08 WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, ALMA LASERS LTD. 510(k) NO: K072182(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200 3637 BERNAL AVE. SE DECISION MADE: 27-JUN-08 PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DR VISION NEO, DR VISION DOU ALMANA MEDICAL IMAGING 510(k) NO: K080614(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 20-JUN-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALZ WEB PACS, VERSION 1.0 ALZ, INC. 510(k) NO: K081304(TRADITIONAL)
ATTN: CYNTHIA NOLTE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 11-JUN-08 NORTH ATTLEBORO, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYMPHONY GLUCOSE MANAGEMENT SYSTEM ANIMAS CORP. 510(k) NO: K080639(TRADITIONAL)
ATTN: AMY SMITH PHONE NO : 484-568-1257 200 LAWRENCE DR. SE DECISION MADE: 24-JUN-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRO-TOUCH NITRAFREE ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K080536(TRADITIONAL)
ATTN: LON D MCIIVAIN PHONE NO : 334-615-2562 1635 INDUSTRIAL RD. SE DECISION MADE: 19-JUN-08 DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOMAD PRO X-RAY SYSTEM ARIBEX, INC. 510(k) NO: K081664(TRADITIONAL)
ATTN: D. CLARK TURNER PHONE NO : 801-226-5522 744 SOUTH 400 EAST SE DECISION MADE: 23-JUN-08 OREM, UT 84651 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GLUCCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEMS ARKRAY FACTORY USA, INC. 510(k) NO: K073416(TRADITIONAL)
ATTN: TOM SPEIKERS PHONE NO : 952-646-3168 5182 WEST 76TH ST. SE DECISION MADE: 13-JUN-08 MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSURE INJFECTABLE PICC ARROW INTERNATIONAL, INC. 510(k) NO: K080604(TRADITIONAL)
ATTN: JULIE LAWSON PHONE NO : 610-378-0131 2400 BERNVILLE RD. SE DECISION MADE: 27-JUN-08 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENSION PYROCARBON LUNATE ASCENSION ORTHOPEDICS, INC. 510(k) NO: K080997(TRADITIONAL)
ATTN: DEBBIE STEARNS PHONE NO : 512-836-5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 17-JUN-08 AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES AVITA CORPORATION 510(k) NO: K081160(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340 2904 N. BOLDT DR. SE DECISION MADE: 24-JUN-08 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRO AXELGAARD MFG. CO., LTD. 510(k) NO: K080580(TRADITIONAL)
ATTN: DAN P JEFFERY PHONE NO : 760-451-8000 520 INDUSTRIAL WAY SE DECISION MADE: 18-JUN-08 FALLBROOK, CA 92028-2244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRONTOSAN WOUND IRRIGATION SOLUTION B. BRAUN MEDICAL, INC. 510(k) NO: K072876(TRADITIONAL)
ATTN: REBECCA STOLARICK PHONE NO : 610-596-2536 901 MARCON BLVD. SE DECISION MADE: 19-JUN-08 ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED BAUSCH & LOMB, INC. 510(k) NO: K080755(TRADITIONAL)
ATTN: DEBRA KETCHUM PHONE NO : 585-338-8638 1400 NORTH GOODMAN ST. SE DECISION MADE: 10-JUN-08 ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOCCULT ICT BECKMAN COULTER, INC. 510(k) NO: K080812(TRADITIONAL)
ATTN: SYLVIA ZORICH PHONE NO : 650-845-3453 200 SOUTH KRAEMER BLVD. W-110 SE DECISION MADE: 25-JUN-08 PO BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA BREA, CA 92822 DEVICE: MRSASELECT - EXTENDED INCUBATION BIO-RAD 510(k) NO: K081212(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 13-JUN-08 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATELIA LYME IGM BIO-RAD 510(k) NO: K081362(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 26-JUN-08 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR BIOCOMPOSITES LTD. 510(k) NO: K081428(SPECIAL) ATTN: SIMON FITZER PHONE NO : 44 178 2338580 KEELE SCIENCE PARK SE DECISION MADE: 20-JUN-08 KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATERLASE, VERSION 3.0 BIOLASE TECHNOLOGY, INC. 510(k) NO: K081589(SPECIAL)
ATTN: IOANA RIZOIU PHONE NO : 949-226-8144 4 CROMWELL SE DECISION MADE: 13-JUN-08 IRVINE, CA 92618-1816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUCLISENS EASYQ ENTEROVIRUS SYSTEM BIOMERIEUX, INC. 510(k) NO: K063261(TRADITIONAL)
ATTN: SANDRA PERREAND PHONE NO : 919-620-2000 100 RODOLPHE ST SE DECISION MADE: 23-JUN-08 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY BIOMERIEUX, INC. 510(k) NO: K080931(TRADITIONAL)
ATTN: NIKITA S MAPP PHONE NO : 314-731-7474 595 ANGLUM RD. SE DECISION MADE: 11-JUN-08 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS BIOMET MANUFACTURING, INC. 510(k) NO: K080088(TRADITIONAL)
ATTN: ROBERT R FRIDDLE PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 11-JUN-08 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: E-POLY TIBIAL BEARINGS BIOMET ORTHOPEDICS, INC. 510(k) NO: K080528(TRADITIONAL)
ATTN: MELISSA STEINWEDEL PHONE NO : 574-372-3970 56 EAST BELL DR. SE DECISION MADE: 17-JUN-08 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM BIOMET SPINE 510(k) NO: K081395(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973-299-9300 100 INTERPACE PARKWAY SE DECISION MADE: 25-JUN-08 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET PHOENIX ANKLE NAIL SYSTEM BIOMET TRAUMA 510(k) NO: K081243(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 27-JUN-08 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES BIOMET, INC. 510(k) NO: K080330(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 11-JUN-08 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN BIORETEC LTD 510(k) NO: K080879(TRADITIONAL)
ATTN: MARI RUOTSALAINEN PHONE NO : 358 320 7789500 HERMIAKATU 22 MODULIGHT BLDG SE DECISION MADE: 24-JUN-08 TAMPERE, FINLAND FI-33720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CAN BIORETEC LTD 510(k) NO: K081392(SPECIAL)
ATTN: MARI RUOTSALAINEN PHONE NO : 358 20 7789500 HERMIANKATU 22 MODULIGHT BLDG SE DECISION MADE: 18-JUN-08 TAMPERE, FINLAND FI-33720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS BIOSITE INCORPORATED 510(k) NO: K080269(TRADITIONAL)
ATTN: DAWN A ALLENBY PHONE NO : 858-805-2154 9975 SUMMERS RIDGE RD SE DECISION MADE: 06-JUN-08 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DVX SPINE SYSTEM BK MEDITECH CO., LTD. 510(k) NO: K080876(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 PO BOX 560 SE DECISION MADE: 04-JUN-08 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMENT BONE VOID FILLER, MODEL A0210 BONESUPPORT AB 510(k) NO: K073316(TRADITIONAL)
ATTN: ANN-CHRISTINE PROVOOST PHONE NO : 464 628 65370 SCHEELEVAGEN 19A SE DECISION MADE: 20-JUN-08 IDEON SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA LUND, SWEDEN SE 223-70 DEVICE: UNI-KNEE 2.0 BRAINLAB AG 510(k) NO: K080678(TRADITIONAL)
ATTN: PER PERSSON PHONE NO : 49 89 9915680 KAPELLENSTRASSE 12 SE DECISION MADE: 06-JUN-08 FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPLAN RT IMAGE BRAINLAB AG 510(k) NO: K080886(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680 KAPELLENSTRASSE 12 SE DECISION MADE: 24-JUN-08 FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEIFICATION TO IPLAN RT DOSE BRAINLAB AG 510(k) NO: K080888(SPECIAL)
ATTN: CARSTEN RAUPACH PHONE NO : 49 89 9915680 KAPELLENSTRASSE 12 SE DECISION MADE: 11-JUN-08 FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD DIGNICARE STOOL MANAGEMENT SYSTEM C.R. BARD, INC. 510(k) NO: K073598(TRADITIONAL)
ATTN: MICHELLE GUDITH PHONE NO : 770-784-6722 8195 INDUSTRIAL BLVD. SE DECISION MADE: 13-JUN-08 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER C.R. BARD, INC. 510(k) NO: K081311(SPECIAL)
ATTN: JIHYUN KIM PHONE NO : 801-595-0700 605 NORTH 5600 WEST SE DECISION MADE: 04-JUN-08 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: SPIRIT CAIRE, INC. 510(k) NO: K080023(SPECIAL)
ATTN: ZULFIQAR A CHOUDARY PHONE NO : 770-425-4470 1800 SANDY PLAINS INDUSTRIAL SE DECISION MADE: 16-JUN-08 PARKWAY, STE.316 510(k) SUMMARY AVAILABLE FROM FDA MARIETTA, GA 30066 DEVICE: CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS CANDELA CORP. 510(k) NO: K081324(SPECIAL)
ATTN: LISA LACROIX PHONE NO : 508-358-7400 530 BOSTON POST ROAD SE DECISION MADE: 17-JUN-08 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL RADIOGRAPHY CXDI-60G CANON, INC. 510(k) NO: K081648(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602 ONE CANON PLAZA SE DECISION MADE: 24-JUN-08 LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MRI PATIENT POSITIONING DEVICES CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K080072(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 04-JUN-08 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, CLINIQA CORPORATION 510(k) NO: K080973(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 774 N. TWIN OAKS VALLEY RD. SE DECISION MADE: 02-JUN-08 SAN MARCOS, CA 92069 510(k) STATEMENT DEVICE: MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM CMA MICRODIALYSIS AB 510(k) NO: K071984(TRADITIONAL)
ATTN: NANCY BLANCO PHONE NO : 978-251-1940 73 PRINCETON STREET SE DECISION MADE: 27-JUN-08 NORTH CHELMSFORD, MA 01863 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTAPEK VBR SYSTEM CO-LIGNE AG 510(k) NO: K072326(TRADITIONAL)
ATTN: DAVID SCHLERF PHONE NO : 925-356-2640 1070 CONRAD AVENUE, SUITE 230 SE DECISION MADE: 24-JUN-08 CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERCI RETRIEVER CONCENTRIC MEDICAL, INC. 510(k) NO: K081305(SPECIAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650-938-2100 301 E. EVELYN AVE. SE DECISION MADE: 05-JUN-08 MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEAMER ARGON SNARE PROBE CONMED CORPORATION 510(k) NO: K081580(TRADITIONAL)
ATTN: KAREN PROVENCHER PHONE NO : 978-964-4232 129 CONCORD RD. SE DECISION MADE: 19-JUN-08 BLDG. #3 510(k) SUMMARY AVAILABLE FROM FDA BILLERICA, MA 01821 THIRD PARTY REVIEW DEVICE: CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL CONMED CORPORATION 510(k) NO: K081634(TRADITIONAL)
ATTN: SHAWN RIEDEL PHONE NO : 303-269-8224 14603 E. FREMONT AVE. SE DECISION MADE: 25-JUN-08 CENTENNIAL, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CABS'AIR COUSIN BIOTECH S.A.S. 510(k) NO: K072962(TRADITIONAL) ATTN: STEPHEN PLOQUIN PHONE NO : 33 03 20144000 8 RUE DE L'ABBE BONPAIN SE DECISION MADE: 26-JUN-08 WERVICQ-SUD, FRANCE 59117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTEN CREASPINE 510(k) NO: K081564(SPECIAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 919-859-4207 49 PLAIN ST. SE DECISION MADE: 30-JUN-08 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 CRYOCATH TECHNOLOGIES, INC. 510(k) NO: K081049(SPECIAL)
ATTN: FRED MILDER PHONE NO : 505-955-8936 52 WEST BASIN RIDGE SE DECISION MADE: 27-JUN-08 GALISTEO, NM 87540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURE CATHETER CLOSED SYSTEM CURE MEDICAL LLC. 510(k) NO: K080881(TRADITIONAL)
ATTN: JAMES SMITH PHONE NO : 949-340-7261 29442 POINTE ROYAL SE DECISION MADE: 11-JUN-08 LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DADE BEHRING, INC. 510(k) NO: K071597(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891 P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 04-JUN-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K071603(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551 GLASGOW SITE, PO BOX 6101 SE DECISION MADE: 25-JUN-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 DATASCOPE CORP., PATIENT MONITORIN510(k) NO: K080175(ABBREVIATED)
ATTN: KATHLEEN KRAMER PHONE NO : 201-995-8169 800 MACARTHUR BLVD. SE DECISION MADE: 09-JUN-08 MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K081620(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 30-JUN-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC. 510(k) NO: K080828(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287 325 PARAMOUNT DR. SE DECISION MADE: 27-JUN-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILV DERMA SCIENCES CANADA, INC. 510(k) NO: K080497(TRADITIONAL)
ATTN: SHARMINI ATHERAY PHONE NO : 416 299 4003 104 SHORTING RD. SE DECISION MADE: 27-JUN-08 TORONTO, ONTARIO, CANADA M1S 3S4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC. 510(k) NO: K081584(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 19-JUN-08 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KI DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K081164(TRADITIONAL)
ATTN: GAIL R GOODRUM PHONE NO : 740-589-3300 1055 EAST STATE STREET SE DECISION MADE: 13-JUN-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA ATHENS, OH 45701 DEVICE: ENDSNOR DOCKSTADER ORTHODONTIC LAB, INC. 510(k) NO: K072731(ABBREVIATED)
ATTN: MICHAEL C BAUSMAN PHONE NO : 559-439-5160 340 WEST CROMWELL SE DECISION MADE: 12-JUN-08 FRESNO, CA 93711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 DORNIER MEDTECH AMERICA, INC. 510(k) NO: K080959(TRADITIONAL)
ATTN: THERON GOBER PHONE NO : 770-514-6204 1155 ROBERTS BLVD. SE DECISION MADE: 27-JUN-08 KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 DUCKWORTH & KENT, LTD. 510(k) NO: K072985(TRADITIONAL) ATTN: MARTIN LOCK PHONE NO : 011 441 462893254 7 MARQUIS BUSINESS CENTRE SE DECISION MADE: 20-JUN-08 ROYSTON RD. 510(k) SUMMARY AVAILABLE FROM FDA BALDOCK, HERTSFORDSHIRE, UNITED KINGDOM SG7 6XL DEVICE: EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION EKOS CORP. 510(k) NO: K081467(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-415-3132 11911 N CREEK PARKWAY SOUTH SE DECISION MADE: 26-JUN-08 BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESKTOP PRO ELEKTA LTD. 510(k) NO: K080585(TRADITIONAL)
ATTN: PATRICK T.M. HULL PHONE NO : 441 293 544422 LINAC HOUSE SE DECISION MADE: 11-JUN-08 FLEMING WAY, CRAWLEY 510(k) SUMMARY AVAILABLE FROM FDA WEST SUSSEX, UNITED KINGDOM RH10 9RR DEVICE: ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES ENDOGASTRIC SOLUTIONS, INC. 510(k) NO: K073644(TRADITIONAL)
ATTN: KEN PERINO PHONE NO : 425-307-9200 8210 154TH AVE. NE SE DECISION MADE: 27-JUN-08 REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM ENTELLUS MEDICAL, INC. 510(k) NO: K081542(SPECIAL)
ATTN: SEW-WAH TAY PHONE NO : 612-801-6782 18555 37TH AVENUE NORTH SE DECISION MADE: 27-JUN-08 PLYMOUTH, MN 55446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIRKONDENT ERGOMETA 510(k) NO: K080146(TRADITIONAL)
ATTN: MIKE ARTEMOV PHONE NO : 949-296-5375 144 LOS FLORES SE DECISION MADE: 06-JUN-08 ALISO VIEJO, CA 92656 510(k) STATEMENT DEVICE: ETHICON ENDO SURGERY ARTICULATING SNARE ETHICON ENDO-SURGERY, INC. 510(k) NO: K073288(TRADITIONAL)
ATTN: GLENDA C MARSH PHONE NO : 513-337-7659 4545 CREEK RD. SE DECISION MADE: 12-JUN-08 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) ETHICON ENDO-SURGERY, LLC 510(k) NO: K081146(TRADITIONAL)
ATTN: ABHILASHA MUKHERJEE PHONE NO : 513-337-3623 4545 CREEK ROAD SE DECISION MADE: 26-JUN-08 CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FALCK APPLANATION TONOMETER (FAT2) FALCK MEDICAL INC. 510(k) NO: K071755(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738 15825 SHADY GROVE RD.,SUITE 30 SE DECISION MADE: 03-JUN-08 ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEEL-FINE INSULIN PEN NEEDLE FEEL TECH 510(k) NO: K080904(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 04-JUN-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSER LP SYSTEM FLOWCARDIA, INC. 510(k) NO: K080765(TRADITIONAL)
ATTN: DUSTIN MICHAELS PHONE NO : 408-617-0352 745 N. PASTORIA AVE. SE DECISION MADE: 20-JUN-08 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WG-SURGICAL SUTURES WITH NEEDLE FOOSIN MEDICAL SUPPLIES INC. 510(k) NO: K080684(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467 SUITE 8D, ZHONGXIN ZHONGSHAN SE DECISION MADE: 09-JUN-08 MANSION, NO. 19 LANE 999 510(k) SUMMARY AVAILABLE FROM FDA ZHONG SHAN, SHANGHAI, CHINA 20030 DEVICE: FREEDOM SCIENCES MOTION CONTROL MODULE (MCM) FREEDOM SCIENCES, LLC 510(k) NO: K073330(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-546-9810 5905 FAWN LANE SE DECISION MADE: 20-JUN-08 CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJIFILM FCR VIEW, MODEL CR-VW674 FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K081308(SPECIAL)
ATTN: DEBRA A PEACOCK PHONE NO : 203-602-3774 419 WEST AVE. SE DECISION MADE: 04-JUN-08 STAMFORD, CT 06902-6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HE4 EIA, MODEL: 404-10 US FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K072939(TRADITIONAL)
ATTN: DIANA L DICKSON PHONE NO : 610-240-3917 201 GREAT VALLEY PKWY. SE DECISION MADE: 09-JUN-08 MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GPS, G SURGICAL PEDICLE SYSTEM G SURGICAL CO., LTD. 510(k) NO: K081041(TRADITIONAL) ATTN: DONALD GRAFTON PHONE NO : 660 263 66842 152 SOI RAMKHAMHAENG 138 SE DECISION MADE: 27-JUN-08 SAPANSUNG 510(k) SUMMARY AVAILABLE FROM FDA BANGKOK, THAILAND 10240 DEVICE: PRISMAFLEX M150 SET GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K080519(TRADITIONAL)
ATTN: KAE MILLER PHONE NO : 303-542-5045 14143 DENVER WEST PARKWAY SE DECISION MADE: 13-JUN-08 LAKEWOOD, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRADIA FORTE GC AMERICA, INC. 510(k) NO: K080478(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-897-4042 3737 WEST 127TH ST. SE DECISION MADE: 05-JUN-08 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GC OPB-100 GC AMERICA, INC. 510(k) NO: K080724(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-926-3042 3737 WEST 127TH ST. SE DECISION MADE: 11-JUN-08 ALSIP, IL 60803 510(k) STATEMENT DEVICE: PRECISION 500D R&F X-RAY SYSTEM GE HEALTHCARE 510(k) NO: K081091(TRADITIONAL)
ATTN: MICHAEL PETROWSKI PHONE NO : 262-548-2673 3000 N GRANDVIEW BLVD. SE DECISION MADE: 11-JUN-08 W-709 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 DEVICE: APEXPRO TELEMETRY SYSTEMS GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K080251(TRADITIONAL)
ATTN: BERNARD SANDLER PHONE NO : 414-362-2090 8200 WEST TOWER AVE. SE DECISION MADE: 20-JUN-08 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCOVERY XR AND XA DIAGNOSTIC IMAGING SYSTEMS GE MEDICAL SYSTEMS, LLC 510(k) NO: K081496(TRADITIONAL)
ATTN: DAVID DUERSTELER PHONE NO : 262-312-7029 3000 N GRANDVIEW BLVD. SE DECISION MADE: 12-JUN-08 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACCELA SYSTEM GENESIS BIOSYSTEMS, INC. 510(k) NO: K081578(TRADITIONAL)
ATTN: STEPHEN J MACDONALD PHONE NO : 972-315-7888 1500 EAGLE COURT SE DECISION MADE: 20-JUN-08 LEWISVILLE, TX 75057 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO GALILEO GOLD HAMILTON MEDICAL AG 510(k) NO: K080181(TRADITIONAL)
ATTN: JOERG SCHNEIDER PHONE NO : 41 81 6606010 VIA CRUSCH 8 SE DECISION MADE: 24-JUN-08 BONADUZ, SWITZERLAND CH-7402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSEI CATHETER CONTROL SYSTEM HANSEN MEDICAL, INC. 510(k) NO: K073225(TRADITIONAL)
ATTN: DOUG WORTH PHONE NO : 650-404-5800 380 NORTH BERNARDO AVE. SE DECISION MADE: 30-JUN-08 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIMESH HERNIAMESH S.R.L. 510(k) NO: K081327(TRADITIONAL)
ATTN: LORENA TRABUCCO PHONE NO : 516-987-9364 8 ORANGE DR. SE DECISION MADE: 19-JUN-08 JERICHO, NY 11753 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K081198(TRADITIONAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 18-JUN-08 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REJUVENATE MODULAR HIP SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K081044(SPECIAL)
ATTN: DENISE DAUGERT PHONE NO : 201-831-5413 325 CORPORATE DR. SE DECISION MADE: 03-JUN-08 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 FEMORAL NAIL HOWMEDICA OSTEONICS CORP. 510(k) NO: K081152(SPECIAL)
ATTN: DANIELLE HILLMAN PHONE NO : 201-831-6365 325 CORPORATE DRIVE SE DECISION MADE: 10-JUN-08 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNEXX LOCKING TIBIA NAIL I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K080706(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858 3150 E. 200TH ST. SE DECISION MADE: 09-JUN-08 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZURA TEE SYSTEM IMACOR LLC 510(k) NO: K080223(TRADITIONAL)
ATTN: STEVEN B DATLOF M.D., J.D. PHONE NO : 267-675-4613 1835 MARKET STREET SE DECISION MADE: 24-JUN-08 28TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA PHILADELPHIA, PA 19103 DEVICE: INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL INTACT MEDICAL CORPORATION 510(k) NO: K081057(TRADITIONAL)
ATTN: DOUGLAS MACARTHUR PHONE NO : 508-655-7820 ONE APPLE HILL SUITE 316 SE DECISION MADE: 17-JUN-08 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUXTEC MLX LIGHT SOURCE INTEGRA LUXTEC, INC. 510(k) NO: K081477(TRADITIONAL)
ATTN: RITA WADLEIGH PHONE NO : 508-835-9700 99 HARTWELL ST. SE DECISION MADE: 18-JUN-08 WEST BOYLSTON, MA 01583 510(k) STATEMENT DEVICE: INTEL HEALTH GUIDE, MODEL: PHS6000 INTEL CORP. 510(k) NO: K080798(ABBREVIATED)
ATTN: TAE-WOONG KOO PHONE NO : 408-765-2060 1900 PRAIRIE CITY RD., FM7-197 SE DECISION MADE: 27-JUN-08 FOLSOM, CA 95630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIATOR TRANSPORT INCUBATOR INTERNATIONAL BIOMEDICAL, LTD. 510(k) NO: K081399(SPECIAL)
ATTN: AMY PIEPER PHONE NO : 512-873-0033 8508 CROSS PARK DR. SE DECISION MADE: 06-JUN-08 AUSTIN, TX 78754 510(k) STATEMENT DEVICE: DC NEURO INVIVO CORPORATION 510(k) NO: K081262(TRADITIONAL)
ATTN: THEODORE J REISKER PHONE NO : 262-524-1402 N27 W23676 PAUL RD. SE DECISION MADE: 17-JUN-08 PEWAUKEE, WI 53072 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ECARD AND CCARD IRHYTHM TECHNOLOGIES, INC. 510(k) NO: K081471(TRADITIONAL)
ATTN: WILLIAM H RIGHTER PHONE NO : 415-252-1400 650 TOWNSEND STREET SE DECISION MADE: 24-JUN-08 SAN FRANCISCO, CA 94103 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: WATCH-PAT 200I (WP200I) ITAMAR MEDICAL 510(k) NO: K081037(SPECIAL)
ATTN: JOHATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 09-JUN-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) IVU IMAGING CORPORATION 510(k) NO: K080555(TRADITIONAL)
ATTN: MARK L STRIBLING PHONE NO : 817-545-9766 4121 GRACE LANE SE DECISION MADE: 03-JUN-08 GRAPEVINE, TX 76051 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RANGE SPINAL SYSTEM, LARGE DENALI SCREWS K2M, INC. 510(k) NO: K081381(SPECIAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 13-JUN-08 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE KALTENBACH & VOIGT GMBH & CO. 510(k) NO: K080677(TRADITIONAL)
ATTN: CLAUDIA ORTIZ PHONE NO : 714-516-7981 1717 WEST COLLINS SE DECISION MADE: 06-JUN-08 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) KIMBERLY-CLARK CORP. 510(k) NO: K081027(ABBREVIATED)
ATTN: RICHARD W WOLFE PHONE NO : 770-587-8208 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 30-JUN-08 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L-VARLOCK KISCOMEDICA S.A. 510(k) NO: K080537(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 30-JUN-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K080523(TRADITIONAL)
ATTN: HEATHER VIELE PHONE NO : 208-377-4800 12554 WEST BRIDGER ST. SE DECISION MADE: 17-JUN-08 SUITE 108 510(k) STATEMENT BOISE, ID 83713 DEVICE: KYMCO FORU, MODEL EQ40 KWANG YANG MOTOR CO., LTD. 510(k) NO: K081133(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396 14F-2, NO.1, ZHUANGJING ROAD SE DECISION MADE: 10-JUN-08 LANE 25 510(k) SUMMARY AVAILABLE FROM FDA BANQIAO, CHINA (TAIWAN) 220 DEVICE: PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCU LAZARUS MEDICAL LLC 510(k) NO: K073702(TRADITIONAL)
ATTN: CYNTHIA J.M NOLTE PHONE NO : 919-859-4207 2129 BENEVENTUM CT SE DECISION MADE: 26-JUN-08 RALEIGH, NC 27606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY LEVITRONIX LLC. 510(k) NO: K081221(TRADITIONAL)
ATTN: SUSAN HAMANN PHONE NO : 781-622-5075 45 FIRST AVE. SE DECISION MADE: 19-JUN-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM LIFESCAN, INC. 510(k) NO: K081318(SPECIAL)
ATTN: FRANK PERALTA PHONE NO : 408-942-3589 1000 GIBRALTAR DR. SE DECISION MADE: 09-JUN-08 MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS S LORENZ BIOTECH S.P.A. 510(k) NO: K080902(ABBREVIATED)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 13-JUN-08 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K081483(SPECIAL)
ATTN: GLORIA LEE PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SE DECISION MADE: 25-JUN-08 TORONTO, ONTARIO, CANADA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSAIC LASER SYSTEM LUTRONIC CORPORATION 510(k) NO: K080932(SPECIAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 09-JUN-08 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWC/DWC WARMING CABINETS MAC MEDICAL 510(k) NO: K080609(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 13-JUN-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II MAKO SURGICAL CORP. 510(k) NO: K080368(TRADITIONAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044 2555 DAVIE RD., SUITE 110 SE DECISION MADE: 20-JUN-08 FT. LAUDERDALE, FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MAQUET CRITICAL CARE AB 510(k) NO: K073179(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 908-947-2311 1140 ROUTE 22 EAST SE DECISION MADE: 09-JUN-08 SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA BRIDGEWATER, NJ 08807 DEVICE: MARTIN CHAIR, MODEL C4S1 MARTIN MANUFACTURING CO., LLC 510(k) NO: K080506(ABBREVIATED)
ATTN: MICHAEL ZAPATA, III PHONE NO : 919-696-7814 621-101 HUTTON ST SE DECISION MADE: 09-JUN-08 RALEIGH, NC 27606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT CABLE MED-DYNE 510(k) NO: K080112(TRADITIONAL)
ATTN: E.W. JOHNSON PHONE NO : 502-429-4140 2775 SOUTH FLOYD ST. SE DECISION MADE: 20-JUN-08 LOUISVILLE, KY 40209 510(k) STATEMENT DEVICE: NEB-90 LARGE VOLUME MEDICATION NEBULIZER MEDI NUCLEAR CORP., INC. 510(k) NO: K080657(TRADITIONAL)
ATTN: MICHAEL MCPECK PHONE NO : 800-321-5981 4610 LITTLEJOHN ST. SE DECISION MADE: 30-JUN-08 BALDWIN PARK, CA 91706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERO, VERSION 2.0 MEDICAL PREDICTIVE SCIENCE CORP. 510(k) NO: K081473(SPECIAL)
ATTN: WILLIAM E KING PHONE NO : 434-220-0714 2246 IVY RD., SUITE 17 SE DECISION MADE: 27-JUN-08 CHARLOTTESVILLE, VA 22903 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE PREMIUM SAFETY NEEDLE SYSTEM MEDPRO SAFETY PRODUCTS, INC. 510(k) NO: K072602(ABBREVIATED)
ATTN: GREG E MITCHELL PHONE NO : 859-244-7548 250 WEST MAIN STREET SE DECISION MADE: 18-JUN-08 SUITE 2700 510(k) SUMMARY AVAILABLE FROM FDA LEXINGTON, KY 40507-1749 DEVICE: MEDRAD INTEGO PET INFUSION SYSTEM MEDRAD, INC. 510(k) NO: K080297(TRADITIONAL)
ATTN: TROY A JACK PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 17-JUN-08 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K081297(SPECIAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 11-JUN-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIS FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K062254(TRADITIONAL)
ATTN: EDWARD CHIN PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 16-JUN-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC EXPORT AP CATHETER MEDTRONIC VASCULAR 510(k) NO: K081573(SPECIAL)
ATTN: TARA N TURNEY PHONE NO : 978-739-6654 37A CHERRY HILL DRIVE SE DECISION MADE: 27-JUN-08 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS MEDXPERT GMBH 510(k) NO: K073556(TRADITIONAL)
ATTN: FRANZ MENEAN PHONE NO : 049 746 3995411 GRIESWEG 47 SE DECISION MADE: 24-JUN-08 MUHLHEIM, BADEN-WURTTEMBERG, GERMA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HORIZON XVU MENNEN MEDICAL LTD. 510(k) NO: K081484(SPECIAL)
ATTN: IFAT OREN PHONE NO : 972 893 23333 4 HAYARDEN ST., YAVNE SE DECISION MADE: 20-JUN-08 P.O.BOX 102 510(k) SUMMARY AVAILABLE FROM FDA REHOVOT, ISRAEL 76100 DEVICE: BONEMEDIK-DM META BIOMED CO., LTD. 510(k) NO: K080772(TRADITIONAL)
ATTN: TAE-HOON KIM PHONE NO : 834 221 81983 414-21 MO CHOONG DONG, SE DECISION MADE: 03-JUN-08 CHONG JU CITY 510(k) SUMMARY AVAILABLE FROM FDA REPUBLIC OF KOREA, REPUBLIC OF KOREA DEVICE: MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K080379(TRADITIONAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1428 821 FOX LANE SE DECISION MADE: 30-JUN-08 SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 MINOS MEDICAL 510(k) NO: K080550(TRADITIONAL)
ATTN: TOM COLONNA PHONE NO : 949-215-1835 15560-C ROCKFIELD BLVD SE DECISION MADE: 10-JUN-08 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SATURN 9000-810 NEW MEDICAL CO., LTD. 510(k) NO: K080589(SPECIAL)
ATTN: YOUNG-HOON SHIN PHONE NO : 886 287 916268 4F, NO.42, SINGZHONG RD. SE DECISION MADE: 11-JUN-08 NEIHU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI, CHINA (TAIWAN) 114 DEVICE: MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO NEW STAR LASERS, INC. 510(k) NO: K081628(SPECIAL)
ATTN: NATALIE R VOLLRATH PHONE NO : 916-677-1900 9085 FOOTHILLS BLVD. SE DECISION MADE: 20-JUN-08 ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLENIUM II NEXT MOBILITY, LLC 510(k) NO: K081665(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320 543 LONG HILL AVENUE SE DECISION MADE: 27-JUN-08 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NILIMEDIX ADI NILIMEDIX LTD. 510(k) NO: K070844(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 06-JUN-08 BINYAMINA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINGER PULSE OXIMETER, MODEL 9560 NONIN MEDICAL, INC. 510(k) NO: K081285(SPECIAL)
ATTN: LORI M ROTH PHONE NO : 763-577-3093 13700 1ST AVE. NORTH SE DECISION MADE: 05-JUN-08 PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 OLYMPIC MEDICAL CORP. 510(k) NO: K081094(SPECIAL)
ATTN: STEVE HESLER PHONE NO : 206-767-3500 5900 FIRST AVE., SOUTH SE DECISION MADE: 20-JUN-08 SEATTLE, WA 98108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) OPTICAL IMAGING LTD. 510(k) NO: K080180(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST. NW SE DECISION MADE: 11-JUN-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100 ORQIS MEDICAL CORPORATION 510(k) NO: K073631(TRADITIONAL)
ATTN: RYAN KELLY PHONE NO : 949-707-5890 14 ORCHARD ROAD, SUITE 100 SE DECISION MADE: 27-JUN-08 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS C ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K081411(SPECIAL)
ATTN: MARLENE A HANNA PHONE NO : 585-453-4041 100 INDIGO CREEK DR. SE DECISION MADE: 30-JUN-08 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM ORTHOPEDIATRICS, LLC 510(k) NO: K081097(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574-268-6379 210 NORTH BUFFALO STREET SE DECISION MADE: 03-JUN-08 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE ORTHOVITA, INC. 510(k) NO: K081439(SPECIAL)
ATTN: DAVID J MCILHENNY PHONE NO : 610-407-5211 45 GREAT VALLEY PKWY. SE DECISION MADE: 17-JUN-08 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCCLUSION BALLOON CATHETER, MODEL VENOS OSCOR INC. 510(k) NO: K081052(TRADITIONAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511 3816 DE SOTO BLVD. SE DECISION MADE: 18-JUN-08 PALM HARBOR, FL 34683 510(k) STATEMENT DEVICE: PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K080675(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 49 770 49291586 KARL-HALL-STRASSE 01 SE DECISION MADE: 20-JUN-08 GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALOMAR LUX 1540 HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K080244(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2300 82 CAMBRIDGE ST. SE DECISION MADE: 20-JUN-08 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA SERIES HYPERBARIC CHAMBER PERRY BAROMEDICAL CORP. 510(k) NO: K072427(ABBREVIATED)
ATTN: JOHN CROCKER PHONE NO : 561-840-0395 3660 INTERSTATE PKWY. SE DECISION MADE: 11-JUN-08 RIVIERA BEACH, FL 33404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K081426(TRADITIONAL)
ATTN: MELINDA NOVATNY PHONE NO : 440-483-4255 595 MINER RD. SE DECISION MADE: 04-JUN-08 CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HD15 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. 510(k) NO: K081661(TRADITIONAL)
ATTN: PHONE NO : 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 24-JUN-08 BOTHELL, WA 98041 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NERVE MONITORING CABLE PIONEER SURGICAL TECHNOLOGY 510(k) NO: K073229(ABBREVIATED)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812 375 RIVER PARK CIRCLE SE DECISION MADE: 06-JUN-08 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM PLASMA SURGICAL, LTD. 510(k) NO: K080197(TRADITIONAL) ATTN: PETER GIBSON PHONE NO : 44 118 9166790 BRUNEL ROAD SE DECISION MADE: 24-JUN-08 THEALE, BERKSHIRE, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE POSSIS MEDICAL, INC. 510(k) NO: K081454(SPECIAL)
ATTN: MIKE BURNSIDE PHONE NO : 763-780-4555 9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 13-JUN-08 MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM PRECISION SURGERY LTD. 510(k) NO: K073708(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457 8202 SHERMAN ROAD SE DECISION MADE: 03-JUN-08 CHESTERLAND, OH 44026-2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED PROCTER & GAMBLE CO. 510(k) NO: K081555(SPECIAL)
ATTN: LENORE FAULHABER PHONE NO : 513-634-2466 6110 CENTER HILL AVE. SE DECISION MADE: 27-JUN-08 CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA QUEST DIAGNOSTICS, INC. 510(k) NO: K080381(TRADITIONAL)
ATTN: LIUMING YU PHONE NO : 913-895-2308 10101 RENNER BLVD. SE DECISION MADE: 25-JUN-08 LENEXA, KS 66219-9752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAMIN AIR REMGENIC LLC 510(k) NO: K080516(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155 24301 WOODSAGE DRIVE SE DECISION MADE: 23-JUN-08 BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERCURY VCO2 MODULE WITH CAPNOSTAT 5 RESPIRONICS NOVAMETRIX LLC 510(k) NO: K080652(SPECIAL)
ATTN: KEVIN MADER PHONE NO : 203-697-6466 5 TECHNOLOGY DRIVE SE DECISION MADE: 20-JUN-08 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K080617(TRADITIONAL)
ATTN: NIELS SCHMIDT PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 27-JUN-08 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TR-USB TELEPHONIC STETHOSCOPE RNK PRODUCTS, INC. 510(k) NO: K081032(TRADITIONAL)
ATTN: CHARLES R ABBRUSCATO PHONE NO : 612-414-0289 12700 DIAMOND DRIVE SE DECISION MADE: 06-JUN-08 BURNSVILLE, MN 55337 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL T ROCHE DIAGNOSTICS CORP. 510(k) NO: K073501(TRADITIONAL)
ATTN: THERESA A BUSH PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 09-JUN-08 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN ROCHE DIAGNOSTICS CORP. 510(k) NO: K080811(TRADITIONAL)
ATTN: KERWIN L KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 20-JUN-08 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUTOPATCH, TUTOMESH RTI BIOLOGICS, INC. 510(k) NO: K081538(SPECIAL)
ATTN: TRAVIS AROLA PHONE NO : 386-418-8888 11621 RESEARCH CIRCLE SE DECISION MADE: 19-JUN-08 P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA ALACHUA, FL 32616-1627 DEVICE: SMARTBURS S.S. WHITE BURS, INC. 510(k) NO: K080687(TRADITIONAL)
ATTN: DEREK GLADDEN PHONE NO : 732-905-1100 1145 TOWBIN AVE. SE DECISION MADE: 20-JUN-08 LAKEWOOD, NJ 08701 510(k) STATEMENT DEVICE: APOLLO MINI IPL SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K081219(TRADITIONAL)
ATTN: MARK ROHRER PHONE NO : 205-290-8251 102 OXMOOR RD. SE DECISION MADE: 30-JUN-08 SUITE 13 510(k) SUMMARY AVAILABLE FROM FDA HOMEWOOD, AL 35209 DEVICE: SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 SECTRA IMTEC AB 510(k) NO: K081469(SPECIAL)
ATTN: CARL ALLETO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 12-JUN-08 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIGENT CREATININE (ENZYMATIC) ASSAY SENTINEL CH. SPA 510(k) NO: K073634(TRADITIONAL)
ATTN: FABIO ROTA PHONE NO : 39 02 34551448 VIA ROBERT KOCH, 2 SE DECISION MADE: 19-JUN-08 MILANO, ITALY 20152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTINEL PLASMAPROTEINS CAL 3X SENTINEL CH. SPA 510(k) NO: K081533(TRADITIONAL)
ATTN: FABIO ROTA PHONE NO : 39 02 34551448 VIA ROBERT KOCH, 2 SE DECISION MADE: 25-JUN-08 MILANO, ITALY 20152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRI SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K081322(TRADITIONAL)
ATTN: CHARLES MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 18-JUN-08 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K081340(TRADITIONAL)
ATTN: CHARLES MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 18-JUN-08 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SHARPS TRANSPORT TUBE, MODEL 50035 SHARPS COMPLIANCE, INC. 510(k) NO: K073577(TRADITIONAL)
ATTN: DAVID OLMSTEAD PHONE NO : 615-278-9292 614 HUNTERS LANE SE DECISION MADE: 23-JUN-08 BRENTWOOD, TN 37027 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K073280(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-JUN-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESICEM SHOFU DENTAL CORP. 510(k) NO: K080517(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760-736-3277 1225 STONE DR. SE DECISION MADE: 11-JUN-08 SAN MARCOS, CA 92078 510(k) STATEMENT DEVICE: VINTAGE ART SHOFU DENTAL CORP. 510(k) NO: K080834(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760-736-3277 1225 STONE DR. SE DECISION MADE: 11-JUN-08 SAN MARCOS, CA 92078 510(k) STATEMENT DEVICE: NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K073537(TRADITIONAL)
ATTN: NOOR MALKI PHONE NO : 781-269-3401 2 EDGEWATER DR. SE DECISION MADE: 27-JUN-08 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM DEFINITION, MODEL AS/AS+ SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K081022(TRADITIONAL)
ATTN: CORRINE MCLEOD PHONE NO : 610-448-1772 51 VALLEY STREAM PKWY. SE DECISION MADE: 02-JUN-08 E-50 510(k) SUMMARY AVAILABLE FROM FDA MALVERN, PA 19355 DEVICE: BIOGRAPH HD FAMILY SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K081453(TRADITIONAL)
ATTN: ALAINE MEDIO PHONE NO : 865-218-2703 810 INNOVATION DR. SE DECISION MADE: 23-JUN-08 KNOXVILLE, TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K081121(TRADITIONAL)
ATTN: MARTINA VOGT PHONE NO : 425-557-1434 1230 SHOREBIRD WAY SE DECISION MADE: 04-JUN-08 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K081332(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457 8202 SHERMAN ROAD SE DECISION MADE: 10-JUN-08 CHSETERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-VOID, SPIDER SINTEA BIOTECH, INC. 510(k) NO: K072198(TRADITIONAL)
ATTN: GUSTAVO A RIOS PHONE NO : 305-673-6226 407 LINCOLN RD. SUITE 10L SE DECISION MADE: 06-JUN-08 MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SL-PLUS STANDARD AND LATERAL HIP STEMS SMITH & NEPHEW, INC. 510(k) NO: K072852(TRADITIONAL)
ATTN: NICHOLAS B TABRIZI PHONE NO : 901-399-6017 1450 BROOKS RD. SE DECISION MADE: 09-JUN-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS SMITH & NEPHEW, INC. 510(k) NO: K081106(SPECIAL)
ATTN: LAURA SEJNOWSKI PHONE NO : 901-399-5349 1450 BROOKS RD. SE DECISION MADE: 18-JUN-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW CDS SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K081491(SPECIAL)
ATTN: MASON W ROBBINS PHONE NO : 901-399-6021 1450 E BROOKS ROAD SE DECISION MADE: 19-JUN-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFL SMITHS MEDICAL ASD, INC. 510(k) NO: K072080(TRADITIONAL)
ATTN: CYNTHIA ENGELHARDT PHONE NO : 603-352-3812 160 WEYMOUTH ST. SE DECISION MADE: 02-JUN-08 ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUREX SYNTHETIC POLYISOPRENE MALE CONDOM SSL AMERICAS, INC. 510(k) NO: K072169(ABBREVIATED)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2157 3585 ENGINEERING DR. SE DECISION MADE: 19-JUN-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: PROVEN STEM EXTENDER STELKAST COMPANY 510(k) NO: K081458(SPECIAL)
ATTN: DONALD A STEVENS PHONE NO : 724-941-6368 200 HIDDEN VALLEY RD. SE DECISION MADE: 06-JUN-08 MCMURRAY, PA 15317 510(k) STATEMENT DEVICE: BROWNE OPA TEST STRIP STERIS CORPORATION 510(k) NO: K081427(SPECIAL)
ATTN: ROBERT SULLIVAN PHONE NO : 440-392-7695 5960 HEISLEY RD. SE DECISION MADE: 11-JUN-08 MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D-ACTOR VIBRATION MASSAGE SYSTEM STORZ MEDICAL AG 510(k) NO: K072809(TRADITIONAL)
ATTN: MICHAEL DAYTON PHONE NO : 813-949-6090 4608 RUE BORDEAUX SE DECISION MADE: 27-JUN-08 LUTZ, FL 33558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THOR ANTERIOR PLATING SYSTEM STRYKER SPINE 510(k) NO: K080773(TRADITIONAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201-760-8296 2 PEARL COURT SE DECISION MADE: 09-JUN-08 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO INREACH SYSTEM SUPERDIMENSION, LTD. 510(k) NO: K081379(SPECIAL)
ATTN: JONATHAN KOVACH PHONE NO : 763-210-4015 161 CHESHIRE LANE NORTH, SE DECISION MADE: 11-JUN-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55441-5433 DEVICE: STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM SURGICRAFT LTD. 510(k) NO: K073109(ABBREVIATED)
ATTN: DONALD W GUTHNER PHONE NO : 646-460-2984 111 HILL ROAD SE DECISION MADE: 04-JUN-08 DOUGLASSVILLE, PA 19518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICRAFT SCREW FIXATION SYSTEM SURGICRAFT LTD. 510(k) NO: K080447(TRADITIONAL)
ATTN: DONALD W GUTHNER PHONE NO : 888-614-9649 111 HILL ROAD SE DECISION MADE: 13-JUN-08 DOUGLASSVILLE, PA 19518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE SUTURES INDIA PVT., LTD. 510(k) NO: K081001(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 91 80 41868000 472 D, 13TH CROSS, 4TH PHASE SE DECISION MADE: 09-JUN-08 PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA BANGALORE, INDIA 560058 DEVICE: MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE SUTURES INDIA PVT., LTD. 510(k) NO: K081002(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 91 80 41868000 472 D, 13TH CROSS, 4TH PHASE SE DECISION MADE: 09-JUN-08 PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA BANGALORE, INDIA 560058 DEVICE: TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE SUTURES INDIA PVT., LTD. 510(k) NO: K081003(TRADITIONAL) ATTN: L.G. CHANDRASEKHAR PHONE NO : 91 80 41868000 472 D, 13TH CROSS, 4TH PHASE SE DECISION MADE: 09-JUN-08 PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA BANGALORE, INDIA 560058 DEVICE: CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORIN TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K080014(TRADITIONAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 09-JUN-08 WUGU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI COUNTY, CHINA (TAIWAN) 241 DEVICE: IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTE TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K080283(TRADITIONAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 27-JUN-08 WUGU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI COUNTY, CHINA (TAIWAN) 248 DEVICE: CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MOD TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K081144(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 23-JUN-08 WUGU TOWNSHIP 510(k) STATEMENT TAIPEI COUNTY, CHINA (TAIWAN) 248 DEVICE: ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) TEIKOKU PHARMA USA, INC. 510(k) NO: K072560(TRADITIONAL)
ATTN: MARGIE NEMCIK-CRUZ PHONE NO : 408-501-1880 1718 RINGWOOD AVE. SE DECISION MADE: 17-JUN-08 SAN JOSE, CA 95131-1711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEB-U-MASK SYSTEM, MODELS 1895, 1896 TELEFLEX MEDICAL, INC. 510(k) NO: K080230(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155 24301 WOODSAGE DR SE DECISION MADE: 09-JUN-08 BONITA SPRINGS, FL 34134-2015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K080034(TRADITIONAL)
ATTN: ANDREA WALLEN PHONE NO : 734-741-6395 6200 JACKSON RD. SE DECISION MADE: 17-JUN-08 ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER THE BINDING SITE, LTD. 510(k) NO: K080384(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 06-JUN-08 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: MODIFICATION TO CORAL SPINAL SYSTEM THEKEN SPINE LLC 510(k) NO: K081414(SPECIAL)
ATTN: DALE DAVISON PHONE NO : 330-475-8600 1800 TRIPLETT BLVD. SE DECISION MADE: 17-JUN-08 AKRON, OH 44306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITE WAND II THOMPSON SURGICAL INSTRUMENTS, INC510(k) NO: K080962(TRADITIONAL)
ATTN: STEPHANIE A KALUCHA PHONE NO : 231-922-5170 10170 EAST CHERRY BEND ROAD SE DECISION MADE: 25-JUN-08 TRAVERSE CITY, MI 49684 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) TITAN SPINE, LLC 510(k) NO: K080615(TRADITIONAL)
ATTN: KEVIN GEMAS PHONE NO : 952-431-5999 10520 BAEHR RD SE DECISION MADE: 17-JUN-08 MEQUON, WI 53092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51 TOKOTU ELECTRIC CO., LTD. 510(k) NO: K081242(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 300 OYA, UEDA SE DECISION MADE: 11-JUN-08 NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTELITE SIGMA QUICK TOKUYAMA DENTAL CORPORATION 510(k) NO: K080940(TRADITIONAL)
ATTN: KEITH BARRITT PHONE NO : 202-783-5070 1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 19-JUN-08 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081065(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 06-JUN-08 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: CSBP-001A BODY ORGAN PERFUSION SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081482(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 11-JUN-08 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: INFX-8000V, INFINIX-CFI AND INFINIX VFI TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081582(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 17-JUN-08 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: INFX-8000C (INFINIX CC-I AND VC-I) TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081621(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 23-JUN-08 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: INFX-8000F (INFINIX CSI AND INFINIX DPI) TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081624(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 23-JUN-08 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: 21.3" (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) TOTOKU ELECTRIC CO., LTD. 510(k) NO: K081055(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469 300 OYA, UEDA SE DECISION MADE: 04-JUN-08 NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 21.3" (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A) TOTOKU ELECTRIC CO., LTD. 510(k) NO: K081056(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469 300 OYA, UEDA SE DECISION MADE: 04-JUN-08 NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WOUNDSTAT TRAUMACURE INC. 510(k) NO: K081183(TRADITIONAL)
ATTN: CAMPBELL HUTTON PHONE NO : 202-822-1850 2001 PENNSYLVANIA AVE. SE DECISION MADE: 19-JUN-08 SUITE 950 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BL TYSON BIORESEARCH, INC. 510(k) NO: K072854(TRADITIONAL)
ATTN: WEN-HAI TSAI PHONE NO : 886 375 85988 5 F., # 22, KE TUNG RD., SE DECISION MADE: 30-JUN-08 SCIENCE BASED INDUSTRIAL PARK 510(k) STATEMENT CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350 DEVICE: ULTIMED ULTICARE SAFETY SYRINGE ULTIMED, INC. 510(k) NO: K080600(TRADITIONAL)
ATTN: CAROLE STAMP PHONE NO : 952-746-8074 5353 WAYZATA BLVD. SE DECISION MADE: 25-JUN-08 SUITE 505 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55416-1334 DEVICE: ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER ULTIMED, INC. 510(k) NO: K081449(TRADITIONAL)
ATTN: C. STAMP PHONE NO : 952-746-8074 5353 WAYZATA BLVD. SE DECISION MADE: 03-JUN-08 SUITE 505 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55416-1334 THIRD PARTY REVIEW DEVICE: PREFERENCE PEDICLE SCREW SYSTEM US SPINE 510(k) NO: K081296(SPECIAL)
ATTN: RICHARD JANSEN, PHARM. D. PHONE NO : 952-431-5999 13540 GUILD AVE SE DECISION MADE: 06-JUN-08 APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: USHIFU STEPPER USHIFU DEVELOPMENT COMPANY, LLC 510(k) NO: K080970(TRADITIONAL)
ATTN: MARE RYAN PHONE NO : 386-785-0100 1450 SOUTH WOODLAND BLVD. SE DECISION MADE: 11-JUN-08 DELAND, FL 32720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE VELOCITY MEDICAL SOLUTIONS, LLC 510(k) NO: K081076(SPECIAL)
ATTN: PAUL SUMNER PHONE NO : 770-448-7529 1733 CANTON LANE SE DECISION MADE: 20-JUN-08 MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE VERTEBRAL TECHNOLOGIES, INC. 510(k) NO: K080673(TRADITIONAL)
ATTN: PHILIP B JARVI PHONE NO : 952-979-1804 14289 YELLOWPINE SE DECISION MADE: 10-JUN-08 ANDOVER, MN 55304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPLEY OMNIAX VESTICON 510(k) NO: K071973(TRADITIONAL)
ATTN: CATHRYN EPLEY PHONE NO : 503-230-0539 2203 NE OREGON STREET SE DECISION MADE: 20-JUN-08 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT VIASYS HEALTHCARE GMBH 510(k) NO: K080734(TRADITIONAL)
ATTN: THOMAS RUST PHONE NO : 499 314 972383 LEIBNIZSTRASSE 7 SE DECISION MADE: 26-JUN-08 HOECHBERG, GERMANY 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 VIASYS MEDSYSTEMS 510(k) NO: K080679(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-403-3484 100 CHADDICK DR. SE DECISION MADE: 27-JUN-08 WHEELING, IL 60090 510(k) STATEMENT DEVICE: DRF 4343 VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K080859(TRADITIONAL)
ATTN: PAOLO C SANTIN PHONE NO : 39 024 88591 VIA DELLE AZALEE 3 SE DECISION MADE: 04-JUN-08 BUCCINASCO, ITALY 20090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPY VIDEO CAMERA SYSTEM VISION SYSTEMS GROUP, A DIVISION O510(k) NO: K081585(SPECIAL)
ATTN: CHRISTINE E NICHOLS PHONE NO : 508-366-3668 10 GREENLAWN AVE SE DECISION MADE: 20-JUN-08 SOUTH GRAFTON, MA 01560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT VISUAL FOOTCARE TECHNOLOGIES, LLC 510(k) NO: K080816(TRADITIONAL)
ATTN: ANDREW SINGER PHONE NO : 866-385-6442 P.O. BOX 760 SE DECISION MADE: 24-JUN-08 SOUTH SALEM, NY 10590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) VITALOGRAPH(IRELAND) LTD. 510(k) NO: K073155(TRADITIONAL)
ATTN: TOM J HEALY PHONE NO : 35 365 6864100 ENNIS INDUSTRIAL ESTATE SE DECISION MADE: 04-JUN-08 GORT ROAD 510(k) SUMMARY AVAILABLE FROM FDA ENNIS, CO. CLARE, IRELAND DEVICE: PRO TENS, MODEL WL-240 RX WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K080304(TRADITIONAL)
ATTN: JENNY HSIEH PHONE NO : 886 229 282112 1FL, NO.16, LANE 454 SE DECISION MADE: 20-JUN-08 JUNGJENG RD. 510(k) SUMMARY AVAILABLE FROM FDA YUNGHE CITY, TAIPEI COUNTY, CHINA (TAIWAN) DEVICE: ZEN PROGRAM (MIND 440 HEARING AID) WIDEX HEARING AID CO., INC. 510(k) NO: K080955(TRADITIONAL)
ATTN: FRANCIS KUK PHONE NO : 630-245-0025 2300 CABOT DRIVE SE DECISION MADE: 27-JUN-08 SUITE 415 510(k) SUMMARY AVAILABLE FROM FDA LISLE, IL 60532 DEVICE: YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K081590(TRADITIONAL)
ATTN: STEVEN CHANG PHONE NO : 02 879 71943 2F, NO. 13, HUANSHAN ROAD SE DECISION MADE: 19-JUN-08 LANE 28, SEC 1 510(k) SUMMARY AVAILABLE FROM FDA NEI HU, TAIPEI, CHINA (TAIWAN) 114THIRD PARTY REVIEW DEVICE: DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES ZEFON INTL. 510(k) NO: K080366(ABBREVIATED)
ATTN: SCOTT RYAN PHONE NO : 352-854-8080 5350 S.W. FIRST LN. SE DECISION MADE: 09-JUN-08 OCALA, FL 34474 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 243 TOTAL WITH SUMMARIES 222 TOTAL WITH STATEMENTS 21
Updated July 7, 2008
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