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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 K881910
Device Name LABELING CHANGE TO SURGICAL FACE MASK
Applicant
Louis M. Gerson Co., Inc.
Middleboro,  MA  02346
Applicant Contact WILLIE YUNG
Correspondent
Louis M. Gerson Co., Inc.
Middleboro,  MA  02346
Correspondent Contact WILLIE YUNG
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/29/1988
Decision Date 05/18/1988
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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