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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K961454
Device Name AMMI MAGNI-GUARD
Applicant
American Medical Mfg., Inc.
9410 Desoto Ave., Unit J
Chatsworth,  CA  91311
Applicant Contact MIKE HOFTMAN
Correspondent
American Medical Mfg., Inc.
9410 Desoto Ave., Unit J
Chatsworth,  CA  91311
Correspondent Contact MIKE HOFTMAN
Regulation Number878.4040
Classification Product Code
LYU  
Date Received04/15/1996
Decision Date 07/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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