FDA 510K (K192020) Indicator, Physical/Chemical Sterilization Process
FDA 510K (K192020) Indicator, Physical/Chemical Sterilization Process
Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K192020
Device Name Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
Applicant STERIS Corporation
Regulation Number 880.2800
Classification Product Code JOJ
Date Received 07/29/2019
Decision Date 09/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
Total pages: 210
Fully redacted pages: 142
Content pages: 68
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