FDA 510(k) Decisions During July, 1979  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K791056 07/30/1979 3M CEMENT REMOVER 3M COMPANY
K791176 07/30/1979 3M COLD/HOT WATER BAG AND WRAP 3M COMPANY
K791094 07/24/1979 3M ORTHOPEDIC CASTING TAPE 3M COMPANY
K791198 07/30/1979 BIBAG AB MEDETT PRODUKTER
K791196 07/30/1979 URIDROP AB MEDETT PRODUKTER
K791197 07/30/1979 URIDROP SPECIAL AB MEDETT PRODUKTER
K790983 07/10/1979 BIFLEX TM TEMPORARY PACING PROBE ADVANCED MEDICAL CONCEPTS, INC.
K790892 07/24/1979 MISTY NEBULIZER AIRLIFE, INC.
K791189 07/17/1979 ECHO CARDIOGRAM PAD ALIMED, INC.
K790797 07/17/1979 AMYLASE REAGENT SET ALTA DIAGNOSTICS, INC.
K790796 07/17/1979 LIPASE REAGENT SET ALTA DIAGNOSTICS, INC.
K791182 07/30/1979 ACMI RIGI-FLEX NEPHORSCOPE AMERICAN CYSTOCOPE MAKERS, INC.
K791159 07/30/1979 DINAMAP MODEL 855 APPLIED MEDICAL RESEARCH
K791165 07/10/1979 ARCOLITH 4000 ARCO MEDICAL PRODUCTS CO.
K791221 07/03/1979 TEGTMEIER MAMMOMETER AZTEC MEDICAL PRODUCTS, INC.
K791105 07/24/1979 B & L OPHTHALMIC CHAIR BAUSCH & LOMB, INC.
K791104 07/24/1979 B & L OPHTHALMIC INSTRUMENT STAND BAUSCH & LOMB, INC.
K791031 07/17/1979 ABNORMAL PROTEIN ELECTROPHORESIS CONTROL BECKMAN INSTRUMENTS, INC.
K791077 07/24/1979 BECKMAN ELECTROPHORESIS OVEN/INCUBATOR BECKMAN INSTRUMENTS, INC.
K791029 07/17/1979 NORMAL PROTEIN ELECTROPHORESIS CONTROL BECKMAN INSTRUMENTS, INC.
K791329 07/30/1979 FLUOROMATIC ANALYZER AND AUTOSAMPLER BIO-RAD
K790576 07/30/1979 QUANTIMUNE T-4 FIA BIO-RAD
K790597 07/10/1979 SENSOMAT SIDEARM ADAPTER BIOCHEM INTERNATIONAL, INC.
K790898 07/30/1979 PREG-TEX BIOLOGICS INTL., INC.
K791186 07/06/1979 MODEL BP-2000 TIME-CYCLED VENTILATOR BOURNS MEDICAL SYSTEMS, INC.
K791239 07/24/1979 BRIOX MODEL 2000-A ASPIRATOR UNIT BRIOX TECHNOLOGIES, INC.
K791240 07/24/1979 BRIOX MODEL 2000-C COMPRESSOR UNIT BRIOX TECHNOLOGIES, INC.
K791241 07/24/1979 BRIOX MODEL 2000-CA COMPRESSOR UNIT BRIOX TECHNOLOGIES, INC.
K791238 07/24/1979 BRIOX MODEL 2000-CQ QUIET COMPRESSOR BRIOX TECHNOLOGIES, INC.
K790853 07/30/1979 EASY-SPEC C. INTL.
K790851 07/30/1979 VAGI-PRESS #401 C. INTL.
K790852 07/30/1979 VAGI-SPEC C. INTL.
K791054 07/10/1979 HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC C.R. BARD, INC.
K790997 07/24/1979 ANTI-DNASE B REAGENT SYSTEM CALBIOCHEM-BEHRING CORP.
K790970 07/03/1979 SURGICAL FACE MASK CARAPACE, INC.
K790836 07/30/1979 GUARDIAN II I.V. CONTROLLER CENTAUR SCIENCES, INC.
K791051 07/24/1979 PROGESTERONE RADIOIMMUNOASSAY KIT CIS RADIOPHARMACEUTICALS, INC.
K791079 07/17/1979 GAMMADAB (125 1) FOLATE RADIOASSAY KIT CLINICAL ASSAYS, INC.
K791086 07/03/1979 CENTRY 2 SYSTEM #016, 103, 016, 104 COBE LABORATORIES, INC.
K791247 07/24/1979 CONPHAR NASAL OXYGEN CANNULA-STERILE CONPHAR, INC.
K791273 07/24/1979 CONPHAR OXYGEN CATHETER-STERILE CONPHAR, INC.
K791253 07/30/1979 CONPHAR SUCTION CATHETER-W/0 CONTROL CONPHAR, INC.
K791248 07/24/1979 SECUTE ELBOW BAND CONPHAR, INC.
K791267 07/24/1979 SECUTEX ANKLE BAND CONPHAR, INC.
K791266 07/24/1979 SECUTEX KNEE BAND CONPHAR, INC.
K791249 07/24/1979 SECUTEX WRIST BRACE CONPHAR, INC.
K780627 07/11/1979 SURG-O-PAK, GOWNS, SHEETS, AND TOWELS CONVERTORS
K790446 07/30/1979 OVALITH-300 CORATOMIC, INC.
K790631 07/30/1979 STERAID SURGICAL DRESSING CORDA INTL. HOLDINGS, INC.
K791276 07/24/1979 PERVENOUS LEAD INTRODUCER SYSTEM CORDIS CORP.
K790667 07/24/1979 CORNING PARAPROTEIN SCREENING CORNING MEDICAL & SCIENTIFIC
K791229 07/30/1979 CYBER DX 100 CYBER DIAGNOSTICS
K791129 07/17/1979 PERMANENT LEAD INTRADUCER DAIG CORP.
K791137 07/24/1979 SINGLE USE MONOPOLAR HAND CONTROL PENCIL DAVOL, INC.
K791166 07/10/1979 DEXIDE DISPOSABLE PREP SPONGE DEXIDE, INC.
K791168 07/30/1979 DEXIDE DISPOSABLE PREP STICK DEXIDE, INC.
K791169 07/30/1979 DEXIDE DISPOSABLE SWAB STICK DEXIDE, INC.
K790914 07/03/1979 SILASTIC INTRAVENOUS CATHETER UNIT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K791183 07/12/1979 SWAN-GANZ FLOW-DIRECTED CATHETER EDWARDS LIFESCIENCES, LLC. SALLY L MAHER
K791219 07/30/1979 UNILITH PULSE GENERATOR ELA MEDICAL, INC.
K791158 07/03/1979 STIMULATOR, ELECTRICAL NERVE ELECTREAT, INC.
K791280 07/24/1979 OPERATION MICROSCOPE SOM 1 ELMED, INC.
K790602 07/30/1979 RIA, DIGNXIN-125-I ENDOCRINE-METABOLIC CENTER
K790630 07/24/1979 RIA, INSULIN, DOUBLE ANTIBODY ENDOCRINE-METABOLIC CENTER
K791018 07/17/1979 FERMCOTEST R BUN RATE REAGENT TEST KIT FERMCO BIOCHEMICS, INC.
K790922 07/30/1979 DISPOSABLE ADULT DIAPER FIBRE FORMATIONS, INC.
K791111 07/30/1979 AUTOMATED ELECTROPHORESES MACHINE GELMAN SCIENCES, INC.
K791108 07/17/1979 CONTEXT FILTER GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K790816 07/17/1979 HEMATRAK MODEL 480 GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K791139 07/10/1979 PREGELLED DISPOSABLE ECG ELECTRODES HAYES PRODUCTS, INC.
K791140 07/10/1979 PREGELLED DISPOSABLE EELCTRO. SERIES 600 HAYES PRODUCTS, INC.
K790883 07/24/1979 STRESS/EMERGENCY EELCTRODE HAYES PRODUCTS, INC.
K791289 07/24/1979 GIZMO TOWEL CLAMP HEMOY, INC.
K791138 07/24/1979 5880 SERIES OF GAS CHROMATOGRAPHS HEWLETT-PACKARD CO.
K791206 07/30/1979 HCG RIA PREGNANCY TEST HOFFMANN-LA ROCHE, INC.
K791151 07/30/1979 ECG CHANNEL OF DIAGNOSTIC SYSTEM HONEYWELL, INC.
K790811 07/30/1979 EXETER BONE LAUAGE SYSTEM HOWMEDICA CORP.
K791305 07/30/1979 FELTLOC CAST PADDING HOWMEDICA CORP.
K790693 07/30/1979 HYPERBARIC OXYGEN CHAMBER HYPERBARIC OXYGEN THERAPY, INC.
K790220 07/31/1979 PACEMAKER PROGRAMMER INTERMEDICS, INC.
K791194 07/17/1979 BRAIN HEART INFUSION BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791292 07/17/1979 BRAIN HEART INFUSION WITH AGAR BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791291 07/17/1979 BRAIN HEART INFUSION WITH BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791193 07/17/1979 NUTRIENT BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791171 07/17/1979 TRYPTIC SOY BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791143 07/17/1979 SICKLE-CELL F TEST ISOLAB, INC.
K791188 07/05/1979 CAM-10 BATTERY PACK (#7-001) LIFECARE SERVICES, INC.
K791033 07/03/1979 CAM-10 PVV PORTABLE VOLUME VENTILATOR LIFECARE SERVICES, INC.
K790605 07/03/1979 RESPIRAOTR, CAM-10 RBL LIFECARE SERVICES, INC.
K791119 07/30/1979 MACOMB NORMAL CONTROL SERUM MACOMB CHEMICAL CO.
K790985 07/17/1979 P.A.P. RIA CONTROL SERUM PACK MALLINCKRODT CRITICAL CARE
K791126 07/17/1979 MODEL CE-DM-II HEARING INSTRUMENT MARCON HEARING INSTRUMENTS, INC.
K790870 07/05/1979 MODEL H63, BEHIND-THE-EAR MARCON HEARING INSTRUMENTS, INC.
K790759 07/30/1979 IIF-APCA TEST KIT MEDICA CORP.
K790429 07/05/1979 MEDTRONIC MODEL 6957 MEDTRONIC VASCULAR
K791065 07/30/1979 IMMUNOSPOT TSH TEST MELOY LABORATORIES, INC.
K791190 07/06/1979 STETHOSCOPE WITH TEMPERATURE SENSOR NATIONAL CATHETER CO. DIV. MALLINCKRODT
K790845 07/24/1979 DUALUME LARYNGEAL EXAMINATION TELESCOPE NATIONAL MEDICAL TECHNOLOGY
K791195 07/30/1979 DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN OHIO NUCLEAR, INC.
K791022 07/24/1979 PROTHROMBIN REFERENCE PLASMA (HUMAN) PACIFIC HEMOSTASIS
K790863 07/17/1979 HUMAN CHORIONIC GONADOTROPHIN STANDARDS PCL-RIA, INC.
K790876 07/17/1979 LABELED HUMAN CHORIONIC GONADOTROPHIN PCL-RIA, INC.
K790864 07/17/1979 RABBIT ANTISERUM TO HUMAN CHORIONIC PCL-RIA, INC.
K791145 07/10/1979 CPR CONTROL SYSTEM PEPIN DISTRIBUTING, INC.
K791156 07/30/1979 AMIPAQUE MYELOGRAM TRAY PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K790339 07/17/1979 CONCEPT II RICHARDSON MERREL, INC.
K791210 07/24/1979 PORTABLE ASPIRATOR SAM SAY ASSOC.
K790822 07/06/1979 ANTERIOR/POSTERIOR RESTORATIVE LIQUID SCIENTIFIC PHARMACEUTICALS, INC.
K790789 07/06/1979 COMPOSITE RESTORATIVE, PASTE/PASTE TYPE SCIENTIFIC PHARMACEUTICALS, INC.
K790788 07/06/1979 FISSURE SEALER AND BONDING AGENT SCIENTIFIC PHARMACEUTICALS, INC.
K790963 07/06/1979 PAINT-ON RESTORATIVE, LIGHT CURED SCIENTIFIC PHARMACEUTICALS, INC.
K790962 07/06/1979 SEAL & BOND DIRECT BONDING ORTHODONTIC SCIENTIFIC PHARMACEUTICALS, INC.
K790875 07/30/1979 MONOJECT ENDOMETRIAL SAMPLING KIT SHERWOOD MEDICAL CO.
K791089 07/10/1979 SHERWOOD NEBULIZER KIT SHERWOOD MEDICAL CO.
K790975 07/30/1979 SOMATOM 2 SIEMENS CORP.
K791214 07/30/1979 TRIDOROS 712 SIEMENS CORP.
K791080 07/24/1979 PLUS CHEM S.C.E. REAGENT SMITH KLINE DIAGNOSTICS, INC.
K791084 07/17/1979 PLUS CHEM, DETERMINATION OF ALT (GPT) SMITH KLINE DIAGNOSTICS, INC.
K791085 07/17/1979 PLUS CHEM, DETERMINATION OF LD (LDH-P) SMITH KLINE DIAGNOSTICS, INC.
K791082 07/17/1979 SPIN CHEM REAGENT, DETERMINATION OF AST SMITH KLINE DIAGNOSTICS, INC.
K791081 07/17/1979 SPIN CHEM REAGENT, DETERMINATION OF LDH- SMITH KLINE DIAGNOSTICS, INC.
K791083 07/17/1979 SPIN CHEM, DETERMINATION OF ALT (GPT) SMITH KLINE DIAGNOSTICS, INC.
K791071 07/03/1979 MODEL MA3 BEHIND-THE-EAR MASKER/HEARING STARKEY LABORATORIES, INC.
K791048 07/03/1979 STIMTECH NEUROMUSCULAR STIMULATOR, C 600 STIMULATION TECHNOLOGY, INC.
K791146 07/30/1979 COLO-TAPE SUBURBAN OSTOMY SUPPLY CO., INC.
K782162 07/24/1979 BATTERY CHARGER, 171 PACEMAKER TELECTRONICS, INC.
K782161 07/24/1979 PULSE GENERATOR, MODEL 171 TELECTRONICS, INC.
K791173 07/30/1979 SURFLO INJECTION PLUG TERUMO AMERICA, INC.
K790795 07/24/1979 MODEL 4000, SPECTROPHOTOMETER THE PERKIN-ELMER CORP.
K791017 07/03/1979 FLOW LIMITER TIMETER INSTRUMENT CORP.
K791218 07/30/1979 INHALATION OPERATED NEBULIZER CODE TRAVENOL LABORATORIES, S.A.
K791102 07/17/1979 CARY 210 SERIES, SPECTROPHOTOMETER VARIAN ASSOC., INC.
K791314 07/30/1979 VERTEBRACE SPINAL SUPPORTS VERTEBRACE, INC.
K790658 07/03/1979 AIRCRAFT TRANSIT ISOLATOR MODEL 121 VICKERS AMERICA MEDICAL CORP.
K790657 07/03/1979 STRETCHER TRANSIT ISOLATER #122 VICKERS AMERICA MEDICAL CORP.
K791286 07/24/1979 WECK MICROSURGICAL KNIFE VISTA MEDICAL PRODUCTS, INC.
K791127 07/30/1979 POSIVAC VITAL SIGNS, INC.
K791309 07/30/1979 UCG-LYPHOTEST WAMPOLE LABORATORIES
K791123 07/10/1979 EAR AND NOSE SPECULA XOMED, INC.
K791120 07/10/1979 MIDDLE EAR PICKS, HOOKS CURETTES, XOMED, INC.
K791059 07/17/1979 POPE OTO-WICK, STERILE & NON-STERILE XOMED, INC.
K791122 07/10/1979 TISSURE RETRACTORS XOMED, INC.


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