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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 K252964
Device Name PRIMED Surgical and Procedure Masks
Applicant
Primed Medical Products, Inc.
200, 2003-91 St Sw
Edmonton,  CA T6X0W8
Applicant Contact Mitra Fard
Correspondent
Primed Medical Products, Inc.
200, 2003-91 St Sw
Edmonton,  CA T6X0W8
Correspondent Contact Mitra Fard
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/17/2025
Decision Date 11/04/2025
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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