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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 K913558
Device Name RELIABLE CONE STYLE FACE MASK
Applicant
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Applicant Contact JILL ALBRITTON
Correspondent
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Correspondent Contact JILL ALBRITTON
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/09/1991
Decision Date 11/07/1991
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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