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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 ultraviolet radiation disinfection chamber device
De Novo Number DEN230067
Device Name Chronos®
Requester
germitec
19 rue vauban
bordeaux,  FR 33000
Contact vincent gardes
Regulation Number880.6511
Classification Product Code
SCS  
Date Received09/28/2023
Decision Date 08/28/2024
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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