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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 K894905
Device Name FACE PROTECTION PAK(TM)
Applicant
Protech Products
11 W. Oxmoor Rd.
Suite 405
Birmingham,  AL  35209
Applicant Contact ALBERT E RITCHEY
Correspondent
Protech Products
11 W. Oxmoor Rd.
Suite 405
Birmingham,  AL  35209
Correspondent Contact ALBERT E RITCHEY
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/01/1989
Decision Date 09/12/1989
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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