TSO3 OZONE CHEMICAL INDICATOR

Indicator, Physical/chemical Sterilization Process

TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC

The following data is part of a premarket notification filed by Technologies Of Sterilization With Oxone, Tso3 Inc with the FDA for Tso3 Ozone Chemical Indicator.

Pre-market Notification Details

Device IDK021161
510k NumberK021161
Device Name:TSO3 OZONE CHEMICAL INDICATOR
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC 33 BLACK WATCH TRAIL Fairport,  NY  14450
ContactCharles O Hancock
CorrespondentCharles O Hancock
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC 33 BLACK WATCH TRAIL Fairport,  NY  14450
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-11
Decision Date2003-08-27
Summary:summary

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