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510(k) K161683

SYSTEM 1E Liquid Chemical Sterilant Processing System by STERIS Corporation — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2016
Date Received
June 17, 2016
Clearance Type
Special
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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