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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 K180342
Device Name SYSTEM 1E Liquid Chemical Sterilant Processing System
Applicant
Steris Corporations
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Jennifer Nalepka
Correspondent
Steris Corporations
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Jennifer Nalepka
Regulation Number880.6885
Classification Product Code
MED  
Date Received02/07/2018
Decision Date 04/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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