SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System

Sterilant, Medical Devices

Steris Corporations

The following data is part of a premarket notification filed by Steris Corporations with the FDA for System 1e Liquid Chemical Sterilant Processing System, System 1 Endo Liquid Chemical Sterilant Processing System.

Pre-market Notification Details

Device IDK190104
510k NumberK190104
Device Name:SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
ClassificationSterilant, Medical Devices
Applicant Steris Corporations 5960 Heisley Road Mentor,  OH  44060
ContactJennifer Nalepka
CorrespondentJennifer Nalepka
Steris Corporations 5960 Heisley Road Mentor,  OH  44060
Product CodeMED  
CFR Regulation Number880.6885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-22
Decision Date2019-03-22

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