VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR

Indicator, Biological Sterilization Process

STERIS Corporation

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

Pre-market Notification Details

Device IDK140708
510k NumberK140708
Device Name:VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
ClassificationIndicator, Biological Sterilization Process
Applicant STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
ContactBill Brodeck
CorrespondentBill Brodeck
STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-21
Decision Date2014-06-16
Summary:summary

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