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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 neuromuscular stimulator and exercise evaluation system
De Novo Number DEN230051
Device Name Myocene
Requester
myocene
quai banning 6
liège,  BE 4000
Contact jean-yves mignolet
Regulation Number882.1871
Classification Product Code
SDX  
Date Received07/27/2023
Decision Date 01/17/2025
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Physical Medicine
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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