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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 K922507
Device Name GERSON ISOLAIR APR PARTICULATE SURGICAL MASK
Applicant
Louis M. Gerson Co., Inc.
Middleboro,  MA  02346
Applicant Contact KATHLEEN A WESLEY
Correspondent
Louis M. Gerson Co., Inc.
Middleboro,  MA  02346
Correspondent Contact KATHLEEN A WESLEY
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/27/1992
Decision Date 11/16/1992
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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