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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 K962443
Device Name N95 FILTERING FACEPIECE
Applicant
Survivair, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Applicant Contact GRACE HOLLAND
Correspondent
Survivair, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Correspondent Contact GRACE HOLLAND
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/24/1996
Decision Date 01/03/1997
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
Predetermined Change
Control Plan Authorized		 No
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