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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 K892837
Device Name STERIL-DERM TRANSPARENT WOUND DRESSING
Applicant
Biointerface Technologies, Inc.
1202 Ann St.
Madison,  WI  53713
Applicant Contact DARLENE M KYLLO
Correspondent
Biointerface Technologies, Inc.
1202 Ann St.
Madison,  WI  53713
Correspondent Contact DARLENE M KYLLO
Regulation Number878.4020
Classification Product Code
NAD  
Date Received04/18/1989
Decision Date 08/01/1989
Decision Substantially Equivalent (SESE)
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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