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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 K863580
Device Name DERMATEC TRANSPARENT FILM DRESSING
Applicant
Dermatec, Inc.
549 Howe Ave.
Shelton,  CT  06484
Applicant Contact STEVEN M TUCHBAND
Correspondent
Dermatec, Inc.
549 Howe Ave.
Shelton,  CT  06484
Correspondent Contact STEVEN M TUCHBAND
Regulation Number878.4020
Classification Product Code
NAD  
Date Received08/28/1986
Decision Date 12/31/1986
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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