STERIZONE 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 Sterilizer.

Pre-market Notification Details

Device IDK153689
510k NumberK153689
Device Name:STERIZONE Sterilizer
ClassificationTwo Or More Sterilant Sterilizer
Applicant TSO3 INC 2505, AVENUE DALTON Quebec,  CA G1p 3s5
ContactNathalie Racette
CorrespondentThomas Richards
IM3, INC 7720 NE HWY 99, SUITE D#110 Vancouver,  WA  98665
Product CodePJJ  
CFR Regulation Number880.6860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-23
Decision Date2016-06-30
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.