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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 K931766
Device Name STERIL-DERM-PLUS TRANSPARENT DRESSING
Applicant
Biointerface Technologies, Inc.
1202 Ann St.
Madison,  WI  53713
Applicant Contact CHRISTOPHER CAPELLI
Correspondent
Biointerface Technologies, Inc.
1202 Ann St.
Madison,  WI  53713
Correspondent Contact CHRISTOPHER CAPELLI
Classification Product Code
FRO  
Date Received04/08/1993
Decision Date 01/24/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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