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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 DEN120019
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 Received12/13/2012
Decision Date 03/11/2014
Decision an (AN)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Post-NSE
Reviewed by Third Party No
Combination Product No