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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name marker, skin
510(k) Number K863280
Device Name DERMAMARKER
Applicant
DERMACARE PRODUCTS, INC.
7651 NATIONAL TURNPIKE
LOUISVILLE,  KT  40214
Applicant Contact KEN POTTS
Correspondent
DERMACARE PRODUCTS, INC.
7651 NATIONAL TURNPIKE
LOUISVILLE,  KT  40214
Correspondent Contact KEN POTTS
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received08/25/1986
Decision Date 09/09/1986
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
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