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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 K874291
Device Name EPI-LOCK T.M. PRIMADERM
Applicant
Derma-Lock Medical Corp.
8200 S. Akron St., Suite 108
P.O. Box 4785
Englewood,  CO  80155
Applicant Contact MICHAEL D RIDDLE
Correspondent
Derma-Lock Medical Corp.
8200 S. Akron St., Suite 108
P.O. Box 4785
Englewood,  CO  80155
Correspondent Contact MICHAEL D RIDDLE
Regulation Number878.4020
Classification Product Code
NAD  
Date Received10/20/1987
Decision Date 11/10/1987
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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