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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 stimulator, nerve, electrical, transcutaneous, for migraine
De Novo Number DEN120019
510(K) Number K122566
Device Name CEFALY
Requester
stx-med sprl
zi des haunts sarts
4e ave. 5
herstal, liege,  BE 4040
Contact jean-yves mignolet
Regulation Number882.5891
Classification Product Code
PCC  
Date Received12/13/2012
Decision Date 03/11/2014
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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