SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

Sterilant, Medical Devices

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for System 1e Liquid Chemical Sterilant Processing System, System 1 Endo Liquid Chemical Sterilant Processing System, Model P6800, System 1 Endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate.

Pre-market Notification Details

Device IDK210737
510k NumberK210737
Device Name:SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
ClassificationSterilant, Medical Devices
Applicant STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
ContactJennifer Nalepka
CorrespondentJennifer Nalepka
STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
Product CodeMED  
CFR Regulation Number880.6885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-11
Decision Date2021-05-12

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