FDA 510(k) Applications Received During May, 1979

FDA 510(k) Number Submission Date Device Name Applicant Contact
K790850 05/04/1979 T.E.N.S.* SINGLE-USE ELECTRODE 3M COMPANY
K790848 05/03/1979 A-GENT QUANTICHROM T4 11A ABBOTT LABORATORIES
K790905 05/11/1979 NUCLEAR SAMPLE READER ABBOTT LABORATORIES
K790976 05/23/1979 RUBAZYME ABBOTT LABORATORIES
K790901 05/10/1979 I.V. TUBING ORGANIZER ACUMED INSTRUMENTS CORP.
K790983 05/25/1979 BIFLEX TM TEMPORARY PACING PROBE ADVANCED MEDICAL CONCEPTS, INC.
K790889 05/07/1979 CIRCUIT, BREATHING (W CONNEC, Y PIECE) AIRLIFE, INC.
K790886 05/07/1979 CORRUGATED FLEXIBLE POLYETHYLENE AIRLIFE, INC.
K790884 05/07/1979 FACE TENT-VINYL AIRLIFE, INC.
K790892 05/07/1979 MISTY NEBULIZER AIRLIFE, INC.
K790885 05/07/1979 NASAL, OXYGEN, CANNULA AIRLIFE, INC.
K790887 05/07/1979 TEE ADAPTER AIRLIFE, INC.
K790890 05/07/1979 TEMPO2-I DISPOSABLE THERMOMETERS AIRLIFE, INC.
K790891 05/07/1979 TEMPO2-II DISPOSABLE THERMOMETERS AIRLIFE, INC.
K790888 05/07/1979 TRACH "T" WITH ONE-WAY VALVES AIRLIFE, INC.
K790847 05/04/1979 EGS MODEL 300 ALFRED V. GRECO
K790840 05/02/1979 THYROID CONTROL SERA CODE QAS.101 AMERSHAM CORP.
K790999 05/29/1979 APOLLO HEART RATE INDICATOR APOLLO PRODUCTS, INC.
K790899 05/09/1979 BACTEC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K790960 05/22/1979 QUANTIMUNE T-3 FIA BIO-RAD
K790898 05/09/1979 PREG-TEX BIOLOGICS INTL., INC.
K791007 05/31/1979 STAT DIFF STAIN BIOSCIENTIFIC
K790872 05/07/1979 ENTERIC TUBE GUIDE BIOSEARCH MEDICAL PRODUCTS, INC.
K790862 05/07/1979 BIOVATION DIGITAL URINOMETER BIOVATION, INC.
K790953 05/22/1979 "BORDISPO" BRAND HYPODERMIC NEEDLE BORDA PRODUCTS, INC.
K790853 05/04/1979 EASY-SPEC C. INTL.
K790854 05/04/1979 FORCEPS #101 AND #102 C. INTL.
K790856 05/04/1979 PROCTOSCOPE #501 C. INTL.
K790855 05/04/1979 SURGICAL DRAPE CLIP #201 C. INTL.
K790851 05/04/1979 VAGI-PRESS #401 C. INTL.
K790852 05/04/1979 VAGI-SPEC C. INTL.
K790982 05/23/1979 INSPIRON NEBULO TM 28 NEBULIZER KIT C.R. BARD, INC.
K790997 05/29/1979 ANTI-DNASE B REAGENT SYSTEM CALBIOCHEM-BEHRING CORP.
K790911 05/14/1979 RIA OF PROGESTERONE CALBIOCHEM-BEHRING CORP.
K790970 05/22/1979 SURGICAL FACE MASK CARAPACE, INC.
K790993 05/29/1979 INSTANT HOT & COLD PACKS CHASE MFG. CO.
K791005 05/30/1979 CHEMODENT CERAMIC METAL CHEMODENT DENTAL LABORATORY
K790920 05/09/1979 INTRACRANIAL PRESSURE MONITORING CODMAN & SHURTLEFF, INC.
K791001 05/29/1979 PENLIGHT/SWAB HOLDER CONCEPT, INC.
K791000 05/29/1979 VITREOUS SUCTION/CUTTER CONCEPT, INC.
K790944 05/18/1979 CITRATE AGAR GEL AND BUFFER SET CORNING MEDICAL & SCIENTIFIC
K790943 05/18/1979 TRISEDTA-BORATE ELECTROPHORESIS FILM AGA CORNING MEDICAL & SCIENTIFIC
K790869 05/07/1979 "CARDIO-SLIDECOMP" CREATIVE INSTRUMENTS
K790824 05/01/1979 REPGREEN ULTRAFILTRATION MONITOR CYBEREX CORP.
K790996 05/29/1979 C.C.F. FEMORAL DEBRIDEMENT PROBE DEPUY, INC.
K790941 05/18/1979 D.T.T. LOCK SCREW INSERTER DEPUY, INC.
K791009 05/31/1979 SANTA CASA DISTRACTOR DEPUY, INC.
K790820 05/01/1979 NON-REBREATHING "T" PIECE DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
K790914 05/14/1979 SILASTIC INTRAVENOUS CATHETER UNIT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K790958 05/22/1979 120 WELL HISTO-PLATE DYNATECH LABORATORIES, INC.
K790957 05/22/1979 HISTO-DISPENSER DYNATECH LABORATORIES, INC.
K790956 05/22/1979 HISTO-OILER DYNATECH LABORATORIES, INC.
K790974 05/23/1979 MIC-2000 INOCULATOR TEMPLATE DYNATECH LABORATORIES, INC.
K790971 05/22/1979 MIC-2000 QUAD INOCULUM TRAY DYNATECH LABORATORIES, INC.
K790990 05/30/1979 REYNOLDS DOUBLE HEMOCLIP APPLIERS EDWARD WECK, INC.
K791006 05/31/1979 SMART BILECTRODES ELECTRONICS FOR MEDICINE, INC.
K791008 05/31/1979 ECA (SPECIAL) HEME BUFFER ELECTROPHORESIS CORP. OF AMERICA
K790823 05/01/1979 VISIO-DISPERS ESPE GMBH (US)
K790902 05/10/1979 INTEGRATED PATIENT STATIONS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K790955 05/22/1979 COVER GARD FEM-GARD, INC.
K790954 05/22/1979 HEEL GARD FEM-GARD, INC.
K790922 05/15/1979 DISPOSABLE ADULT DIAPER FIBRE FORMATIONS, INC.
K790995 05/29/1979 CONTEX FOAM TEK, INC.
K790973 05/23/1979 "LO-ION" GAMMA BIOLOGICALS, INC.
K790942 05/18/1979 RADVIEW IMAGER SYSTEM GENERAL ELECTRIC CO.
K790948 05/21/1979 TEMP-GUARD TM GORDON CONSULTANTS, INC.
K790846 05/04/1979 MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) GRASON-STADLER, INC.
K790871 05/07/1979 ENCLOSED CASE CART HAMILTON INDUSTRIES, INC.
K790966 05/22/1979 ULTRASONIC HUMIDIFIER HANKSCRAFT DIV. OF GERBER PRODUCTS CO.
K790883 05/09/1979 STRESS/EMERGENCY EELCTRODE HAYES PRODUCTS, INC.
K790939 05/18/1979 MODEL 78501A PATIENT MONITORING SYSTEM HEWLETT-PACKARD CO.
K790842 05/02/1979 SUBCUTANEOUS TISSUE EXPANDER HEYER SCHULTE CORP.
K790849 05/03/1979 H-H FIXATION AND JOINING CONNECTORS HOLTER-HAUSNER INTL.
K790984 05/25/1979 KLIP-LITE INNOVATORS, INC.
K790882 05/08/1979 LEAD INTRODUCER SET INTROSTAT
K790968 05/22/1979 CATHETER METAL HUB/NONRADIOPAQUE JELCO LABORATORIES
K790967 05/22/1979 CATHETER METAL HUB/RADIOPAQUE JELCO LABORATORIES
K790935 05/16/1979 DELTON* PIT AND FISSURE SEALENT JOHNSON & JOHNSON PROFESSIONALS, INC.
K790894 05/08/1979 URITRON URINE METER JOSEPH F. DANIEL, C.R.N.A.
K790972 05/22/1979 KIMLON IMPERVIOUS STOCKINETTES KIMBERLY-CLARK CORP.
K791024 05/30/1979 ULTRASONIC DENTAL PROPHYLAXIS UNIT LITTON DENTAL PRODUCTS
K790947 05/18/1979 AUTO ENZYMATIC CHOLESTEROL MACOMB CHEMICAL CO.
K790985 05/25/1979 P.A.P. RIA CONTROL SERUM PACK MALLINCKRODT CRITICAL CARE
K790870 05/07/1979 MODEL H63, BEHIND-THE-EAR MARCON HEARING INSTRUMENTS, INC.
K790952 05/22/1979 CLAMP COVERS MEDI-SPEC
K790988 05/25/1979 MODEL 6971 W/ DBS WIRE MEDTRONIC VASCULAR
K790928 05/15/1979 3-WAY "T" 22MM MALE MEM MEDICAL, INC.
K790932 05/15/1979 AEROSOL MOUTHPIECE NO. M-091 MEM MEDICAL, INC.
K790931 05/15/1979 CORRUGATED TUBE WITH MOUTHPIECE MEM MEDICAL, INC.
K790929 05/15/1979 DRAINAGE BAG MEM MEDICAL, INC.
K790933 05/15/1979 MOUTHPIECE M-187 MEM MEDICAL, INC.
K790924 05/15/1979 NEBULIZER NO. M-175 MEM MEDICAL, INC.
K790925 05/15/1979 NEBULIZER WITH 4-WAY T NO M-174 MEM MEDICAL, INC.
K790926 05/15/1979 NEBULIZER WITH MOUTHPIECE AND TEE MEM MEDICAL, INC.
K790934 05/15/1979 OXYGEN BARB M-552 MEM MEDICAL, INC.
K790927 05/15/1979 OXYGENERATOR NO. M-049 MEM MEDICAL, INC.
K790930 05/15/1979 TRACHE FITTING M-307 MEM MEDICAL, INC.
K790992 05/29/1979 PSEUDO-PALETTE TM MICRO-PALETTES, INC.
K790991 05/29/1979 YEAST-PALETTE TM MICRO-PALETTES, INC.
K790906 05/11/1979 AUTOPAK CORTISOL TEST DELIVERY SYSTEM MICROMEDIC SYSTEMS
K790907 05/11/1979 AUTOPAK TEST DELIVERY SYSTEM MICROMEDIC SYSTEMS
K790965 05/22/1979 REAGENT STRIPS FOR URINALYSIS MILES LABORATORIES, INC.
K790845 05/04/1979 DUALUME LARYNGEAL EXAMINATION TELESCOPE NATIONAL MEDICAL TECHNOLOGY
K790843 05/02/1979 SNAP-WAY NORTHWEST ORTHODONTICS, INC.
K790961 05/22/1979 LIQUID SCINTILLATION COUNTER NUCLEAR ENT. LTD.
K790861 05/07/1979 MOIRE CONTOURGRAPH, MODELS MS-1, SS-1 OTAL PRECISION CO. LTD.
K790873 05/07/1979 MODEL 221 PROGRAMALITH PULSE GENERATOR PACESETTER SYSTEMS
K791023 05/30/1979 PROTHROMBIN FREE BEEF PLASMA (PFB) PACIFIC HEMOSTASIS
K791022 05/30/1979 PROTHROMBIN REFERENCE PLASMA (HUMAN) PACIFIC HEMOSTASIS
K790879 05/07/1979 ULTIPOR SOLUTION CONTAINER FILTER PALL BIOMEDICAL PRODUCTS CO.
K790863 05/07/1979 HUMAN CHORIONIC GONADOTROPHIN STANDARDS PCL-RIA, INC.
K790876 05/07/1979 LABELED HUMAN CHORIONIC GONADOTROPHIN PCL-RIA, INC.
K790864 05/07/1979 RABBIT ANTISERUM TO HUMAN CHORIONIC PCL-RIA, INC.
K790909 05/14/1979 OPHTHALMIC DRESSING TRAY PENT-CAL, INC.
K790895 05/07/1979 TONGUE SCRAPER PETER G. FINAMORE, SR.
K790896 05/08/1979 TWO-WAY ANESTHESIA FILTER PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K791002 05/29/1979 ECG ELECTRODES, PEDIATRIC-FOAM TAPE PHYSIO-CONTROL CORP.
K791003 05/29/1979 ECG ELECTRODES, PEDIATRIC-MICROPOROUS TA PHYSIO-CONTROL CORP.
K790959 05/22/1979 LIFEPATCH ECG ELECTRODES PHYSIO-CONTROL CORP.
K790860 05/07/1979 RT-HOOD PLASTICS SUPPLIES & PRODUCTS
K790949 05/21/1979 GALVANIC UNIT RAMI INTERNATIONAL CORP.
K790858 05/03/1979 PERMOBIL EXTERIOR SAAB-SCANIA OF AMERICA, INC.
K790859 05/03/1979 PERMOBIL SUPERIOR SAAB-SCANIA OF AMERICA, INC.
K790950 05/21/1979 S/A 7800 BIRTH SUPPORT CHAIR SCHLOSSER ALBERTI CO.
K790951 05/21/1979 SA/7860 FETAL HEART MONITOR (DOPPLER) SCHLOSSER ALBERTI CO.
K790822 05/01/1979 ANTERIOR/POSTERIOR RESTORATIVE LIQUID SCIENTIFIC PHARMACEUTICALS, INC.
K790963 05/22/1979 PAINT-ON RESTORATIVE, LIGHT CURED SCIENTIFIC PHARMACEUTICALS, INC.
K790962 05/22/1979 SEAL & BOND DIRECT BONDING ORTHODONTIC SCIENTIFIC PHARMACEUTICALS, INC.
K790969 05/22/1979 ARGYLE URINE METER SHERWOOD MEDICAL CO.
K790865 05/07/1979 LANCER HDL SEPARATION KIT SHERWOOD MEDICAL CO.
K790875 05/07/1979 MONOJECT ENDOMETRIAL SAMPLING KIT SHERWOOD MEDICAL CO.
K790838 05/01/1979 ARTERIAL EMBOLECTOMY CATHETER (MODIFIED) SHILEY, INC.
K790938 05/18/1979 SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO SHILEY, INC.
K790975 05/23/1979 SOMATOM 2 SIEMENS CORP.
K790923 05/15/1979 MI-MARK ENDOCERVICAL SAMPLING SET SIMPSON/BASYE, INC.
K790916 05/14/1979 CK-NUC REAGENT SMITH KLINE DIAGNOSTICS, INC.
K790918 05/14/1979 ESKLAB REAGENT TABLETS SMITH KLINE DIAGNOSTICS, INC.
K790917 05/14/1979 SPIN CHEM CK-NAC REAGENT SMITH KLINE DIAGNOSTICS, INC.
K790841 05/02/1979 TG 2, TRI-GARD PRESSURE MONITOR SORENSEN RESEARCH
K790877 05/07/1979 BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO STACKHOUSE ASSOC.
K790904 05/11/1979 STAO-HOTPACK STAODYNAMICS, INC.
K790897 05/09/1979 QUAD IV CUSTOM IMPRESSION TRAY STED, INC.
K790937 05/18/1979 EMIT AUTO DIGOXIN ASSAY SYVA CO.
K790919 05/14/1979 HPL RIA KIT TECHNIA DIAGNOSTICS LTD.
K790867 05/07/1979 CARDIAC PULSE GENERATOR, 16 SERIES TELECTRONICS, INC.
K790868 05/07/1979 GENERATOR, 16 SERIES, MODIFIED TOP CAP TELECTRONICS, INC.
K791021 05/30/1979 MUSCLE TESTING GUN THE ORTHODYN CO.
K790912 05/14/1979 ARIDYNE 3500 TIMETER INSTRUMENT CORP.
K790903 05/11/1979 TRACOR MODEL RA-411 MICROPROCESSOR TRACOR INSTRUMENTS, INC.
K790893 05/08/1979 STAT VARIAN ASSOC., INC.
K790908 05/14/1979 RIA, TEST SET CENTRIA T3 VENTREX LABORATORIES, INC.
K790945 05/18/1979 MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU VICKERS AMERICA MEDICAL CORP.
K790936 05/18/1979 MODEL 114 TREONIC H150 HAEMOHEATER VICKERS AMERICA MEDICAL CORP.
K790878 05/07/1979 SCREENING AUDIOMETER, HIGH FREQUENCY VICON INSTRUMENT CO.
K790874 05/07/1979 "AMALCAP-NON-GAMMA-2" VIVADENT (USA), INC.
K790986 05/25/1979 RF CONTROLS WAMPOLE LABORATORIES
K790946 05/18/1979 GORDON "IVS" INTRAVENOUS STABILIZER WHITMAN MEDICAL CORP.
K790866 05/07/1979 "14 KARAT CASTING GOLD" WILLIAMS GOLD REFINING CO., INC.
K790915 05/14/1979 JUHN TYM-TAP XOMED, INC.
K790987 05/25/1979 ZIMMER R TOTAL SHOULDER II ZIMMER, INC.


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