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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name indicator, biological sterilization process
510(k) Number K202721
Device Name Celerity 20 Steam Biological Indicator for IUSS
Applicant
STERIS Corporation
5976 Heisley Rd
Mentor,  OH  44060
Applicant Contact Anthony Piotrkowski
Correspondent
STERIS Corporation
5976 Heisley Rd
Mentor,  OH  44060
Correspondent Contact Anthony Piotrkowski
Regulation Number880.2800
Classification Product Code
FRC  
Date Received09/17/2020
Decision Date 01/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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