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510(k) K180342

SYSTEM 1E Liquid Chemical Sterilant Processing System by Steris Corporations — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2018
Date Received
February 7, 2018
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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