STERIZONE VP4 Test Pack

Indicator, Biological Sterilization Process

TSO3 Inc., Now A Part Of Stryker

The following data is part of a premarket notification filed by Tso3 Inc., Now A Part Of Stryker with the FDA for Sterizone Vp4 Test Pack.

Pre-market Notification Details

Device IDK203560
510k NumberK203560
Device Name:STERIZONE VP4 Test Pack
ClassificationIndicator, Biological Sterilization Process
Applicant TSO3 Inc., Now A Part Of Stryker 2505, Avenue Dalton Québec,  CA G1p 3s5
ContactKaran Modi
CorrespondentKaran Modi
TSO3 Inc., Now A Part Of Stryker 2505, Avenue Dalton Québec,  CA G1p 3s5
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-03-24

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