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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K863389
Device Name UNITED WOUND COVERING, PACKAGE OF 5
Applicant
United Medical
11775 Starkey Rd.
P.O. Box 1970
Largo,  FL  34649
Applicant Contact MORTON M WYGODSKI
Correspondent
United Medical
11775 Starkey Rd.
P.O. Box 1970
Largo,  FL  34649
Correspondent Contact MORTON M WYGODSKI
Classification Product Code
FRO  
Date Received09/03/1986
Decision Date 11/17/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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