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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K203560
Device Name STERIZONE VP4 Test Pack
Applicant
TSO3 Inc., Now a part of Stryker
2505, avenue Dalton
Québec,  CA G1P 3S5
Applicant Contact Karan Modi
Correspondent
TSO3 Inc., Now a part of Stryker
2505, avenue Dalton
Québec,  CA G1P 3S5
Correspondent Contact Karan Modi
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/07/2020
Decision Date 03/24/2021
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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