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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pediatric/Child Facemask
510(k) Number K213427
Device Name PRIMED Pediatric Facemask
Applicant
Primed Medical Products, Inc.
200, 2003-91 St., SW Edmonton,
Edmonton,  CA T6X 0W8
Applicant Contact Mitra Fard
Correspondent
Primed Medical Products, Inc.
200, 2003-91 St., SW Edmonton,
Edmonton,  CA T6X 0W8
Correspondent Contact Mitra Fard
Regulation Number878.4040
Classification Product Code
OXZ  
Date Received10/21/2021
Decision Date 11/22/2022
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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