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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 K964358
Device Name AMSEAL SURGICAL FACE MASK
Applicant
AMERICAN SEAL CO.
25029 VIKING ST.
HAYWARD,  CA  94545
Applicant Contact LISA CHEN
Correspondent
AMERICAN SEAL CO.
25029 VIKING ST.
HAYWARD,  CA  94545
Correspondent Contact LISA CHEN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/01/1996
Decision Date 02/14/1997
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
Recalls CDRH Recalls
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