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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 K212106
Device Name Relivion
Applicant
Neurolief , Ltd.
12 Giborei Israel St.
Netanya,  IL 4250412
Applicant Contact Michal Kedar-Datel
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2320
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.5891
Classification Product Code
PCC  
Date Received07/06/2021
Decision Date 08/02/2021
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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