STERIZONE VP4 Sterilizer

Two Or More Sterilant Sterilizer

TSO3 Inc

The following data is part of a premarket notification filed by Tso3 Inc with the FDA for Sterizone Vp4 Sterilizer.

Pre-market Notification Details

Device IDK172191
510k NumberK172191
Device Name:STERIZONE VP4 Sterilizer
ClassificationTwo Or More Sterilant Sterilizer
Applicant TSO3 Inc 2505 Avenue Dalton Quebec,  CA G1p 3s5
ContactAlexandre Jokic
CorrespondentCynthia G. Pritchard
BioTechnology Transfer, LLC 1016 Tobiano Lane Raleigh,  NC  27614
Product CodePJJ  
CFR Regulation Number880.6860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-20
Decision Date2018-05-09
Summary:summary

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