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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name qualitative cleaning process protein indicator
De Novo Number DEN230085
Device Name VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
Requester
steris
5960 heisley rd.
mentor,  OH  44060
Contact anthony piotrkowski
Regulation Number880.6930
Classification Product Code
SDC  
Date Received12/18/2023
Decision Date 11/12/2024
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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