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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 K915066
Device Name DISPOSABLE SKIN MARKER
Applicant
AMERICAN MEDICAL MFG., INC.
22231 MULHOLLAND HWY.
CALABASAS,  CA  91302
Applicant Contact MIKE HOFTMAN
Correspondent
AMERICAN MEDICAL MFG., INC.
22231 MULHOLLAND HWY.
CALABASAS,  CA  91302
Correspondent Contact MIKE HOFTMAN
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received11/08/1991
Decision Date 05/14/1992
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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