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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K233777
Device Name PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
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 Number880.6850
Classification Product Code
FRG  
Date Received11/24/2023
Decision Date 05/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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