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510(k) K211607

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 by STERIS Corporation — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2021
Date Received
May 25, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type

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Other clearances for product code MED

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  • K210737 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (May 12, 2021)
  • K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (December 10, 2019)
  • K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (September 5, 2019)
  • K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chem (March 22, 2019)
  • K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (January 31, 2019)
  • K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System (April 4, 2018)
  • K173256 — System 1 endo Liquid Chemical Sterilant Processing System (March 2, 2018)