FDA 510K (K183294) Indicator, Biological Sterilization Process
FDA 510K (K183294) Indicator, Biological Sterilization Process
Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K183294
Device Name CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
Applicant STERIS Corporation
Regulation Number 880.2800
Classification Product Code FRC
Date Received 11/27/2018
Decision Date 01/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
Total pages: 246
Fully redacted pages: 139
Content pages: 107
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