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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 K212071
Device Name Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx
Applicant
Cefaly Technology
Rue Louis Plescia, 34
Seraing,  BE 4102
Applicant Contact Rufus Kay Moberly
Correspondent
Elexes Medical Consulting, LLC
30 N Gould St., Suite R
Sheridan,  WY  82801
Correspondent Contact Parul Chansoria
Regulation Number882.5891
Classification Product Code
PCC  
Date Received07/02/2021
Decision Date 12/13/2022
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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