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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 K131078
Device Name SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
Applicant
STERIS Corporation
5960 HEISLEY
MENTOR,  OH  44060
Applicant Contact MARCIA L BENEDICT
Correspondent
STERIS Corporation
5960 HEISLEY
MENTOR,  OH  44060
Correspondent Contact MARCIA L BENEDICT
Regulation Number880.6885
Classification Product Code
MED  
Date Received04/17/2013
Decision Date 07/05/2013
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
Recalls CDRH Recalls
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