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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 K223717
Device Name Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact Gregory Land
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact Gregory Land
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/12/2022
Decision Date 06/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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