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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 K864371
Device Name SURGICAL SKIN MARKER
Applicant
Myocure, Inc.
1736 Flower St.
Glendale,  CA  91201
Applicant Contact C.JENSEN, M.D.
Correspondent
Myocure, Inc.
1736 Flower St.
Glendale,  CA  91201
Correspondent Contact C.JENSEN, M.D.
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received11/05/1986
Decision Date 11/17/1986
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
Predetermined Change
Control Plan Authorized		 No
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