VERIFY PROCESS INDICATOR FOR RELIANCE EPS

Indicator, Physical/chemical Sterilization Process

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Process Indicator For Reliance Eps.

Pre-market Notification Details

Device IDK130160
510k NumberK130160
Device Name:VERIFY PROCESS INDICATOR FOR RELIANCE EPS
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
ContactMarcia L Benedict
CorrespondentMarcia L Benedict
STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-23
Decision Date2013-08-16
Summary:summary

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