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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 K251666
Device Name SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44094
Applicant Contact Jennifer Nalepka
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44094
Correspondent Contact Jennifer Nalepka
Regulation Number880.6885
Classification Product Code
MED  
Date Received05/30/2025
Decision Date 04/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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