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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 Ave. 5
Herstal,  BE 4040
Applicant Contact JEAN-YVES MIGNOLET
Correspondent
Cefaly Technology
Zi Des Hauts Sarts, 4eme Ave. 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
Predetermined Change
Control Plan Authorized		 No
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