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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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mis aural acoustic screener MAICO HEARING INSTRUMENTS, INC. k791170 06/25/1979
medtronic model 6972 MEDTRONIC VASCULAR k790462 04/16/1979
impervious sterile stockinette ANAGO, INC. k790634 04/10/1979
ceptor hesive MED GENERAL k790269 02/26/1979
astra-vac AB ASTRA k782115 02/01/1979
isolation sleeve, model 349-01 INTERMEDICS, INC. k790098 01/24/1979
change in sterilization procedure ABSORBENT COTTON CO., INC. k781727 12/04/1978
single vial ldh-l tris BOEHRINGER MANNHEIM CORP. k781538 10/03/1978
ultrafill- ultrabound DEMETRON RESEARCH CORP. k781345 08/31/1978
bio-monitor amikacin MONITOR SCIENCE CORP. k780949 08/14/1978

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