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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K802373
Device Name SURGICAL FACE MASK
Applicant
Louis M. Gerson Co., Inc.
MA 
Correspondent
Louis M. Gerson Co., Inc.
MA 
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/29/1980
Decision Date 11/12/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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