510(k) K183295

Celerity HP Chemical Indicator (CI) by Steris Corporations — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2019
Date Received
November 27, 2018
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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