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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hood, Surgical
510(k) Number K904276
Device Name DISPOSABLE BEARD COVER
Applicant
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Applicant Contact ANN FAULKER
Correspondent
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Correspondent Contact ANN FAULKER
Regulation Number878.4040
Classification Product Code
FXY  
Date Received09/19/1990
Decision Date 11/21/1990
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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