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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retention Device, Suture
510(k) Number K893995
Device Name DERMACARE TIE HOLDER
Applicant
Dermacare
7651 National Tpke.
Louisville,  KY  40214
Applicant Contact RYAN SELL
Correspondent
Dermacare
7651 National Tpke.
Louisville,  KY  40214
Correspondent Contact RYAN SELL
Regulation Number878.4930
Classification Product Code
KGS  
Date Received06/05/1989
Decision Date 08/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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