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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 in situ polymerizing peripheral nerve repair device
De Novo Number DEN240066
Device Name COAPTIUM Connect with TISSIUM LIGHT
Requester
tissium sa
74 rue du faubourg saint antoine
paris,  FR 75012
Contact clara defraye
Regulation Number882.5270
Classification Product Code
SFD  
Date Received11/21/2024
Decision Date 06/17/2025
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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