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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 K081633
Device Name PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
Applicant
Primed Medical Products, Inc.
Suite 900, 10707-100 Ave.
Edmonton, Alberta,  CA T5J 3M1
Applicant Contact RAYMOND G MARUSYK
Correspondent
Primed Medical Products, Inc.
Suite 900, 10707-100 Ave.
Edmonton, Alberta,  CA T5J 3M1
Correspondent Contact RAYMOND G MARUSYK
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/11/2008
Decision Date 08/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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