510(k) K182827

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 by STERIS Corporation — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2019
Date Received
October 5, 2018
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