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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 automated endoscope channel cleaner
De Novo Number DEN240018
Device Name CORIS System
Requester
nanosonics limited
7-11 talavera rd.
macquarie park,  AU 2113
Contact nancy kaiser
Regulation Number880.6994
Classification Product Code
SEW  
Date Received05/01/2024
Decision Date 03/19/2025
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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