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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 K160237
FOIA Releasable 510(k) K160237
Device Name Cefaly
Applicant
CEFALY TECHNOLOGY
ZI DES HAUTS SARTS, 4EME AVENUE 5
HERSTAL,  BE 4040
Applicant Contact JEAN-YVES MIGNOLET
Correspondent
CEFALY TECHNOLOGY
ZI DES HAUTS SARTS, 4EME AVENUE 5
HERSTAL,  BE 4040
Correspondent Contact JEAN-YVES MIGNOLET
Regulation Number882.5891
Classification Product Code
PCC  
Date Received02/01/2016
Decision Date 03/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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