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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Accessories
510(k) Number K915068
Device Name PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER
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 Number878.4580
Classification Product Code
FTA  
Date Received11/08/1991
Decision Date 02/06/1992
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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