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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863279
Device Name SURGI-TEK TUBE POSITIONER
Applicant
Dermacare Products, Inc.
7651 National Tpke.
Louisville,  KT  40214
Applicant Contact KEN POTTS
Correspondent
Dermacare Products, Inc.
7651 National Tpke.
Louisville,  KT  40214
Correspondent Contact KEN POTTS
Date Received08/25/1986
Decision Date 09/09/1986
Decision Substantially Equivalent (SESE)
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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