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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 K872100
Device Name BIOFILM TRANSORBENT ULCER AND WOUND DRESSING
Applicant
The Bfgoodrich Co.
9921 Brecksville Rd.
Brecksville,  OH  44141
Applicant Contact EUGENE C GILBERT
Correspondent
The Bfgoodrich Co.
9921 Brecksville Rd.
Brecksville,  OH  44141
Correspondent Contact EUGENE C GILBERT
Regulation Number878.4020
Classification Product Code
NAD  
Date Received06/01/1987
Decision Date 06/30/1987
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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