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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K170956
Device Name SYSTEM 1E Liquid Chemical Sterilant Processing System
Applicant
STERIS Corporation
5960 Heisley Rd
Mentor,  OH  44060
Applicant Contact Tricia Cregger
Correspondent
STERIS Corporation
5960 Heisley Rd
Mentor,  OH  44060
Correspondent Contact Tricia Cregger
Regulation Number880.6885
Classification Product Code
MED  
Date Received03/31/2017
Decision Date 09/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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