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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, Occlusive
510(k) Number K875253
Device Name BFGOODRICH BIOTHANE NON-ADHERENT DRESSING
Applicant
The Bfgoodrich Co.
1220 L St., NW
Suite 615
Washington,  DC  20005
Applicant Contact BRUCE F MACKLER
Correspondent
The Bfgoodrich Co.
1220 L St., NW
Suite 615
Washington,  DC  20005
Correspondent Contact BRUCE F MACKLER
Regulation Number878.4020
Classification Product Code
NAD  
Date Received12/22/1987
Decision Date 04/13/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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