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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 K192929
Device Name SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact Jennifer Nalepka
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact Jennifer Nalepka
Regulation Number880.6885
Classification Product Code
MED  
Date Received10/17/2019
Decision Date 12/10/2019
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
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