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510(k) K190104

Device
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
Applicant
Steris Corporations
510(k) number
K190104
Product code
MED  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-22
Date received
2019-01-22
Regulation
880.6885
Classification name
Sterilant, Medical Devices
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer Nalepka
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MED  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation2026-04-08
K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)STERIS Corporation2023-10-03
K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation2023-03-28
K222615SYSTEM 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 ConcentrateSTERIS Corporation2022-09-28
K211607SYSTEM 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 ConcentrateSTERIS Corporation2021-09-07
K210737SYSTEM 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 ConcentrateSTERIS Corporation2021-05-12
K192929SYSTEM 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 P6900STERIS Corporation2019-12-10
K191343SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation2019-09-05
K182827SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation2019-01-31
K180342SYSTEM 1E Liquid Chemical Sterilant Processing SystemSteris Corporations2018-04-04
K173256System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation2018-03-02
K170956SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation2017-09-22
K161683SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation2016-08-05
K140703OPA 30 SOLUTIONCiden Technologies, LLC2014-08-19
K131078SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation2013-07-05