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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 K871770
Device Name AMERICAN PHARMASEAL WOUND DRESSING
Applicant
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Applicant Contact ROBERT T MERRICK
Correspondent
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Correspondent Contact ROBERT T MERRICK
Classification Product Code
FRO  
Date Received05/06/1987
Decision Date 06/26/1987
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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