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510(k) K252680

Celerity™ 20 HP Biological Indicator by STERIS Corporation — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2025
Date Received
August 25, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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