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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 K905143
Device Name SKIN MARKER
Applicant
AESCULAP, INC.
875 STANTON RD.
BURLINGAME,  CA  94010
Applicant Contact VICTORIA MACKINNON
Correspondent
AESCULAP, INC.
875 STANTON RD.
BURLINGAME,  CA  94010
Correspondent Contact VICTORIA MACKINNON
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received11/15/1990
Decision Date 02/06/1991
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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