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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, disposable
510(k) Number K915064
Device Name DISPOSABLE CAUTERY ABRASIVE PAD
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 Number878.4800
Classification Product Code
KDC  
Date Received11/08/1991
Decision Date 03/11/1992
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
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