STERIZONE CHEMICAL INDICATOR

Indicator, Physical/chemical Sterilization Process

TSO3 INC.

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

Pre-market Notification Details

Device IDK141698
510k NumberK141698
Device Name:STERIZONE CHEMICAL INDICATOR
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant TSO3 INC. 512F NE 81ST STREET, SUITE 110 Vancouver,  WA  98665
ContactThomas Richards, Ph.d.
CorrespondentThomas Richards, Ph.d.
TSO3 INC. 512F NE 81ST STREET, SUITE 110 Vancouver,  WA  98665
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-24
Decision Date2014-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00690455438109 K141698 000

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