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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 K863578
Device Name DERMATEC ZONE TRANSPARENT DRESSING
Applicant
Dermatec, Inc.
91 Bunker Hill Dr.
Trumbull,  CT  06611
Applicant Contact STEVEN M TUCHBAND
Correspondent
Dermatec, Inc.
91 Bunker Hill Dr.
Trumbull,  CT  06611
Correspondent Contact STEVEN M TUCHBAND
Regulation Number878.4020
Classification Product Code
NAD  
Date Received08/28/1986
Decision Date 11/25/1986
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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