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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K840957
Device Name ANTIMICROBIAL INCISE DRAPE
Applicant
American Convertors Div., American Pharmaseal
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Convertors Div., American Pharmaseal
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/06/1984
Decision Date 06/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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