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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K260766
Device Name Celerity 5 HP Biological Indicator (LCB052)
Applicant
STERIS Corporation
5960 Heisley Rod
Mentor,  OH  44060
Applicant Contact Logan Persons
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact Logan Persons
Regulation Number880.2800
Classification Product Code
FRC  
Date Received03/09/2026
Decision Date 04/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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