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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 K890128
Device Name FACELOCK FILTER MASK
Applicant
Alpha Protech, Inc.
6102 S. Memorial
Tulsa,  OK  74133
Applicant Contact W. C KLINTWORTH
Correspondent
Alpha Protech, Inc.
6102 S. Memorial
Tulsa,  OK  74133
Correspondent Contact W. C KLINTWORTH
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/12/1989
Decision Date 02/14/1989
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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