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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 K233681
Device Name ConFirm 20 Minute Incubator
Applicant
Steris Corporation
5960 Heisley Rd
Mentor,  OH  44060
Applicant Contact Logan Persons
Correspondent
Steris Corporation
5960 Heisley Rd
Mentor,  OH  44060
Correspondent Contact Logan Persons
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/16/2023
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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