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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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reinforced tracheostomy tube set(tentat) NATIONAL CATHETER CO. DIV. MALLINCKRODT k810321 03/04/1981
bone fixaction screw SERRANO INTL. k810497 03/11/1981
enzymatic triglyceride POINTE SCIENTIFIC, INC. k810680 03/31/1981
araluen head shield ARALUEN, INC. k810868 05/13/1981
polyethylene medullary plug ARTHUR A. CHECCHI, INC. k811060 05/01/1981
base metal alloy DENTSPLY INTL. k811258 07/23/1981
neisseria-kwik WINDSOR LABORATORIES, INC. k811412 06/16/1981
cardiozyme plus ck-total item #65046 (a) HARLECO k811576 06/25/1981
galactosid-ase tubes MICROCHEMICAL SPECIALITIES, CO. k811854 07/16/1981
percussor DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. k812166 08/18/1981

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