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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, electrical, transcutaneous, for migraine
510(k) Number K122566
Device Name CEFALY
Original Applicant
zi des haunts sarts
4e avenue 5
herstal, liege,  BE 4040
Original Contact jean-yves mignolet
Regulation Number882.5891
Classification Product Code
Date Received08/22/2012
Decision Date 03/11/2014
Decision de novo petitions granted (AN)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No