FDA 510(k) Decisions During September, 1976  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K760611 09/21/1976 3M BRAND ANESTHESIA FILTER,#3110 3M COMPANY
K760593 09/16/1976 PORTABLE CARDIAC MONITOR, ABBY ABBOTT LABORATORIES
K760361 09/13/1976 BLADE, SURGICAL SCALPEL, STERILE AEROCEUTICALS
K760364 09/13/1976 HANDLE, SCALPEL, STAINLESS STEEL AEROCEUTICALS
K760362 09/13/1976 LANCET, BLOOD, STERILE STAINLESS STEEL AEROCEUTICALS
K760363 09/13/1976 SCALPEL, SURGICAL, STERILE STAINLESS AEROCEUTICALS
K760663 09/27/1976 MVP-10 PEDIATRIC/NEONATAL VENTILATOR AIR-SHIELDS, INC.
K760104 09/21/1976 RESPIRATION MONITOR AIR-SHIELDS, INC.
K760512 09/03/1976 TOOTHBRUSH ASSET SCIENTIFIC & PHARMACEUTICAL, INC.
K760680 09/27/1976 INTERMITTENT MANDATORY VENTILATION B & F MEDICAL PRODUCTS, INC.
K760458 09/03/1976 BOTTLE, BLOOD CULTURE, SCHAEDLER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760459 09/03/1976 MUELLER HINTON AGAR W/HEMOGLOBIN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760460 09/03/1976 SCHAEDLER SELECTIVE AGAR-KV BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760457 09/03/1976 SCHAEDLER-SELECTIVE AGAR CNA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760453 09/13/1976 REGULATOR, PRESSURE, CUFF BOEHRINGER LABORATORIES
K760599 09/15/1976 DENTAL CHAIRS CHAYES VIRGINIA, INC.
K760251 09/15/1976 SET, ORAL ADMINISTRATION CIS RADIOPHARMACEUTICALS, INC.
K760624 09/17/1976 SMALL VESSEL CANNULA COBE LABORATORIES, INC.
K760471 09/15/1976 LAMP, FLOURESCENT BLACK, HIGH OUTPUT DERMATRON CORP.
K760482 09/15/1976 SUNLAMP (F40-UVB & F20-UVB) DERMATRON CORP.
K760519 09/03/1976 SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 DERMATRON CORP.
K760320 09/30/1976 PROTECTOR, SURGICAL INSTRUMENT DEVON INDUSTRIES, INC.
K760650 09/21/1976 RETRACTOR, GERBODE STERNAL DILLING CO.
K760571 09/15/1976 FLOSS-A-LOT E. T. SKINNER
K760602 09/21/1976 SORVALL EMBEDDING MEDIUM E.I. DUPONT DE NEMOURS & CO., INC.
K760423 09/15/1976 ELECTROLYSIS MACHINE (PERMATRON) EPCO HAIR REMOVAL CORP.
K760604 09/13/1976 EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS. EUREKA X-RAY TUBE CORP.
K760567 09/15/1976 BACTERIA FILTER FOREGGER AIR PRODUCTS & CHEM., INC.
K760565 09/16/1976 VENTILATOR CIRCUITS FOREGGER AIR PRODUCTS & CHEM., INC.
K760296 09/08/1976 ADJUSTER, WHEELCHAIR WIDTH, BK-6470 FRED SAMMONS, INC.
K760305 09/08/1976 BALLOONS, BK-8112, 8114 FRED SAMMONS, INC.
K760289 09/08/1976 BRUSH, DISPOSA-A (HANDLE, REFILL PKG) FRED SAMMONS, INC.
K760287 09/08/1976 BUTTON AID W/POCKET CLIP, BK-2011 FRED SAMMONS, INC.
K760290 09/08/1976 CANE OR CRUTCH PARKER (3/4, 7/8, L") FRED SAMMONS, INC.
K760304 09/08/1976 CANOPY, PARACHUTE, BK-8110 FRED SAMMONS, INC.
K760306 09/08/1976 CARDS, GIANT FACE PLAYING BK-9419 FRED SAMMONS, INC.
K760295 09/08/1976 CARPET COVERS FOR FOOTRESTS, BK-6467 FRED SAMMONS, INC.
K760297 09/08/1976 CARRIER, FOLDING LUGGAGE, BK-6511 FRED SAMMONS, INC.
K760285 09/08/1976 CONE, HAND, BK-1501 FRED SAMMONS, INC.
K760281 09/08/1976 CUP HOLDER/CUP, WHEELCHAIR FRED SAMMONS, INC.
K760282 09/08/1976 CUP HOLDER/CUP,BK-1140 FRED SAMMONS, INC.
K760292 09/08/1976 DESK, BEANBAG SHUFFLE, BK-6059 FRED SAMMONS, INC.
K760303 09/08/1976 FORK, TUNING BK-7519 FRED SAMMONS, INC.
K760284 09/08/1976 GLASS, NOSEY CUTOUT, BK-1146 FRED SAMMONS, INC.
K760283 09/08/1976 GLASS, SIP N' STRAW WITH LID, 1143 FRED SAMMONS, INC.
K760302 09/08/1976 GONIOMETER, INTER. STAND. LARGE, BK7514 FRED SAMMONS, INC.
K760301 09/08/1976 GONIOMETER, MED. INTER. STAND. BK-7512 FRED SAMMONS, INC.
K760291 09/08/1976 HOLDER, PENCIL & CRAYON, WITH STAND FRED SAMMONS, INC.
K760294 09/08/1976 LEVERS, DOOR KNOB, BK-6395 FRED SAMMONS, INC.
K760293 09/08/1976 MIRROR, EXTEND-A-, BK-6235 FRED SAMMONS, INC.
K760300 09/08/1976 PADDING, TEMPER STICK FOAM, BK-7175 FRED SAMMONS, INC.
K760286 09/08/1976 SPOON, SOFT FOOD FEEDER, BK-1473 FRED SAMMONS, INC.
K760299 09/08/1976 STRIP, CLOSED CELL FOAM, BK-7171 FRED SAMMONS, INC.
K760298 09/08/1976 SUPPORT, WRIST, FIRM WIRE-FOAM FRED SAMMONS, INC.
K760288 09/08/1976 VIEWER, RECLINING, BK-4089 FRED SAMMONS, INC.
K760595 09/17/1976 CARDIAC PROBE G.D. SEARLE AND CO.
K760527 09/03/1976 T-PAD GAYMAR INDUSTRIES, INC.
K760559 09/10/1976 PATIENT MONITORING SYSTEM GENERAL ELECTRIC CO.
K760007 09/03/1976 BLOOD-SMEARING INSTRUMENT (MINIPREP TM) GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K760533 09/09/1976 CATHETER, FLOW DIRECTED THERMAL DILUTION GOULD, INC.
K760532 09/09/1976 COMPUTER, CARDIAC OUTPUT (#SP1425) GOULD, INC.
K760030 09/13/1976 CLINICARD PHOSPHORUS HARLECO
K760028 09/15/1976 CPK - ISOENZYMES HARLECO
K760029 09/15/1976 ENZYMATIC TRIGLYCERIDE HARLECO
K760484 09/03/1976 STAIN SET, HISTOCHEMICAL AFB HARLECO
K760026 09/21/1976 ULTRAZYME AMYLASE HARLECO
K760542 09/09/1976 ELECTROCARDIOGRAPH (#1505A) HEWLETT-PACKARD CO.
K760523 09/03/1976 MONITOR SCOPE HEWLETT-PACKARD CO.
K760539 09/09/1976 RECORDER (#78640A) HEWLETT-PACKARD CO.
K760488 09/03/1976 AIRWAY, DUAL CHANNEL HUDSON OXYGEN THERAPY SALES CO.
K760489 09/03/1976 NEBULIZER, HANDHELD (T "UP-DRAFT) HUDSON OXYGEN THERAPY SALES CO.
K760329 09/30/1976 MASK, DISPOSABLE OXYGEN THERAPY INHAL-O-TECH MEDICAL PLASTIC
K760425 09/13/1976 TAMPON, PLAYTEX 2 VERSION A INTL. PLAYTEX, INC.
K760518 09/03/1976 ADAPTER, PER-CEN-TOX-BODY LANDMARK PLASTICS
K760551 09/05/1976 CANNULA, LARRIAT LANDMARK PLASTICS
K760491 09/15/1976 TUMBLER, GENERAL MEDICAL MEDI-PAK LANDMARK PLASTICS
K760568 09/15/1976 SINGLE PHASE X-RAY CONTROLS & HV GENERATORS LITTON MEDICAL SYSTEMS
K760569 09/15/1976 THREE PHASE X-RAY CONTROLS & HV GENERATORS LITTON MEDICAL SYSTEMS
K760620 09/21/1976 SALIVA EJECTOR LORVIC CORP.
K760635 09/21/1976 MEDI-DYNE APNEA MONITOR MED DYNE INST., INC.
K760223 09/07/1976 SCANNER, ULTRASOUND BODY/HEART MEDISCRA, INC.
K760668 09/27/1976 SELECTATEC SYSTEM MEDISHIELD, INC.
K760481 09/15/1976 FILTER, PARTICULATE ARRESTING MILES LABORATORIES, INC.
K760656 09/27/1976 DETARTRINE Z MR. J. GARRICK EISENBERG
K760359 09/02/1976 ELECTRODE, BOVIE DISPERSIVE NIXON, HARGRAVE, DEVANS
K760580 09/21/1976 DRUG NEBULIZER OHIO MEDICAL PRODUCTS
K760578 09/27/1976 BALANCED CAST SOLE PARKE-DAVIS CO.
K760564 09/10/1976 DEMODULATOR SERIES 1400 PHYSIO-CONTROL CORP.
K760563 09/10/1976 ECG MODULATOR PHYSIO-CONTROL CORP.
K760645 09/21/1976 CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP PILLING CO.
K760646 09/21/1976 CAROTID ARTERY CLAMP W/PILLING LMM PILLING CO.
K760648 09/21/1976 TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS PILLING CO.
K760503 09/27/1976 STIMULATOR, ELECTRICAL MUSCLE (#MD-8) R. A. FISCHER CO. CORP.
K760683 09/27/1976 ALARM, THERMAL, THERM-ALERT RESPIRATORY CARE, INC.
K760435 09/27/1976 PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT RICHARD'S MEDICAL EQUIP., INC.
K760439 09/27/1976 PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY RICHARD'S MEDICAL EQUIP., INC.
K760438 09/21/1976 SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY RICHARD'S MEDICAL EQUIP., INC.
K760659 09/27/1976 CALCIPULPE SEPTODONT, INC.
K760658 09/27/1976 DETARTRINE P SEPTODONT, INC.
K760660 09/27/1976 HYDROL SEPTODONT, INC.
K760657 09/27/1976 RACESTYPTINE CORD SEPTODONT, INC.
K760623 09/27/1976 LANCER PARAPLAST HISTO PROCESS CASSETTE SHERWOOD MEDICAL INDUSTRIES
K760057 09/13/1976 TEST, RIA, TRIODOTHYRONINE SMITH KLINE DIAGNOSTICS, INC.
K760612 09/21/1976 SPACELABS SERIES 1000 SPACELABS, INC.
K760261 09/27/1976 DETECTOR, MODEL LC-100 FLUORESCENCE THE PERKIN-ELMER CORP.
K760483 09/03/1976 BLOOD-SOLUTION ADMINISTRATION SET, SURG. TRAVENOL LABORATORIES, S.A.
K760505 09/03/1976 SOLUTION ADMINISTRATION SET (#2C0631) TRAVENOL LABORATORIES, S.A.
K760500 09/03/1976 TUBE, HEAVY GLASS WALL INJECTION UNIMETRICS CORP.
K760427 09/09/1976 CATHETER, DOVER SUCTION W/ GLOVE WILL ROSS CO.
K760515 09/03/1976 DISC THINNER, WILL-CERUM LIQUID WILLIAMS GOLD REFINING CO., INC.
K760514 09/03/1976 DISC, WILL-CERUM LIQUID WILLIAMS GOLD REFINING CO., INC.
K760570 09/21/1976 ROBINSON MIDDLE EAR PROSTHESIS XOMED, INC.
K760441 09/16/1976 BODY WARMER (SHAKE-N-WARM) YAMADA CO., LTD OF JAPAN
K760609 09/21/1976 EYEGLASS HEARING AID ZENITH HEARING INSTRUMENT CO.


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