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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 K905749
Device Name SURGICAL FACE MASK
Applicant
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Applicant Contact STEVEN ROBINSON
Correspondent
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Correspondent Contact STEVEN ROBINSON
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/24/1990
Decision Date 03/04/1991
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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