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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 K234029
Device Name CEFALY Connected - OTC, CEFALY Connected - Rx
Applicant
Cefaly Technology
Rue Louis Plescia, 34
Seraing,  BE 4102
Applicant Contact Jennifer Trainor
Correspondent
Elexes Medical Consulting
30 N Gould St., Suite R
Sheridan,  WY  82801
Correspondent Contact Parul Chansoria
Regulation Number882.5891
Classification Product Code
PCC  
Date Received12/20/2023
Decision Date 07/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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