Celerity 20 Steam Biological Indicator For IUSS

Indicator, Biological Sterilization Process

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Celerity 20 Steam Biological Indicator For Iuss.

Pre-market Notification Details

Device IDK202721
510k NumberK202721
Device Name:Celerity 20 Steam Biological Indicator For IUSS
ClassificationIndicator, Biological Sterilization Process
Applicant STERIS Corporation 5976 Heisley Rd Mentor,  OH  44060
ContactAnthony Piotrkowski
CorrespondentAnthony Piotrkowski
STERIS Corporation 5976 Heisley Rd Mentor,  OH  44060
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-17
Decision Date2021-01-08

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.