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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 K955556
Device Name FLUID RESISTANT MASK
Applicant
American Threshold Healthcare
P.O. Box 1209
240 Sardis Rd.
Enka,  NC  28728
Applicant Contact FRANCES MAYHEW
Correspondent
American Threshold Healthcare
P.O. Box 1209
240 Sardis Rd.
Enka,  NC  28728
Correspondent Contact FRANCES MAYHEW
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/05/1995
Decision Date 04/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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