TSO3 OZONE STERILIZATION WRAP

Wrap, Sterilization

TSO3 INC.

The following data is part of a premarket notification filed by Tso3 Inc. with the FDA for Tso3 Ozone Sterilization Wrap.

Pre-market Notification Details

Device IDK080198
510k NumberK080198
Device Name:TSO3 OZONE STERILIZATION WRAP
ClassificationWrap, Sterilization
Applicant TSO3 INC. 33 BLACK WATCH TRAIL Fairport,  NY  14450
ContactCharles O Hancock
CorrespondentCharles O Hancock
TSO3 INC. 33 BLACK WATCH TRAIL Fairport,  NY  14450
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-25
Decision Date2008-05-30
Summary:summary

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