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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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zinc paste bandage SECOL CO. k802791 12/17/1980
emerg. oxygen kit #65350 & #65399 case B & F MEDICAL PRODUCTS, INC. k802644 12/22/1980
mycology culture system ORION DIAGNOSTICA, INC. k802946 12/22/1980
hyperalimentation dressing change tray AMERICAN MEDICAL DISPOSABLE, INC. k803114 12/22/1980
normal and elevated control for glyco. APPLIED CLINICAL RESEARCH LABORATORIES k803186 01/21/1981
limb orhtosis MEDICAL DESIGN & MANUFACTURING CORP. k810222 02/04/1981
acridine orange stain BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC k810040 02/12/1981
quinton lte electrode QUINTON, INC. k810563 03/17/1981
x-ray image intensifier products INSTRUMENTATION CAMERA, INC. k810716 04/23/1981
breath meter FRED SAMMONS, INC. k810437 05/01/1981

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