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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 cap
De Novo Number DEN230061
Device Name allay Nerve Cap
Requester
tulavi therapeutics
160 knowles ave.
lost gatos,  CA  95032
Contact corinne bright
Regulation Number882.5260
Classification Product Code
SBG  
Date Received09/12/2023
Decision Date 07/16/2024
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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