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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 K171446
Device Name Cefaly Acute
CEFALY Technology
Rue Louis Plescia 34
Seraing,  BE 4102
Applicant Contact Jean-Yves Mignolet
CEFALY Technology
Rue Louis Plescia 34
Seraing,  BE 4102
Correspondent Contact Jean-Yves Mignolet
Regulation Number882.5891
Classification Product Code
Date Received05/16/2017
Decision Date 09/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02616978
Reviewed by Third Party No
Combination Product No