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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
TSO3 Inc
2505 Avenue Dalton
quebec,  CA g1p 3s5
Applicant Contact alexandre jokic
BioTechnology Transfer, LLC
1016 Tobiano Lane
raleigh,  NC  27614
Correspondent Contact cynthia g. pritchard
Regulation Number880.6860
Classification Product Code
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