VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

Indicator, Biological Sterilization Process

STERIS Corporations

The following data is part of a premarket notification filed by Steris Corporations with the FDA for Verify V24 Self-contained Biological Indicator, Verify V24 Biological Indicator Challenge Pack.

Pre-market Notification Details

Device IDK183300
510k NumberK183300
Device Name:VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
ClassificationIndicator, Biological Sterilization Process
Applicant STERIS Corporations 5960 Heisley Road Mentor,  OH  44060
ContactGregory Land
CorrespondentGregory Land
STERIS Corporations 5960 Heisley Road Mentor,  OH  44060
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-27
Decision Date2019-01-03
Summary:summary

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