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510(k) K220473

CELERITY 20 HP Challenge Pack by Steris — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2022
Date Received
February 18, 2022
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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