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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Two Or More Sterilant Sterilizer
510(k) Number K172191
Device Name STERIZONE VP4 Sterilizer
Applicant
Tso3, Inc.
2505 Ave. Dalton
Quebec,  CA G1P 3S5
Applicant Contact Alexandre Jokic
Correspondent
Biotechnology Transfer, LLC
1016 Tobiano Ln.
Raleigh,  NC  27614
Correspondent Contact Cynthia G. Pritchard
Regulation Number880.6860
Classification Product Code
PJJ  
Date Received07/20/2017
Decision Date 05/09/2018
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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