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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 K092012
Device Name PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
Applicant
Primed Medical Products, Inc.
Suite 900, 10707-100 Ave.
Edmonton, Alberta,  CA T5J 3M1
Applicant Contact RAYMOND MARUSYK
Correspondent
Primed Medical Products, Inc.
Suite 900, 10707-100 Ave.
Edmonton, Alberta,  CA T5J 3M1
Correspondent Contact RAYMOND MARUSYK
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/06/2009
Decision Date 09/25/2009
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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