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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
Neurolief Ltd.
12 Giborei Israel St.
Netanya,  IL 4250412
Applicant Contact Michal Kedar-Datel
Hogan Lovells US LLP
1735 Market Street, Suite 2320
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.5891
Classification Product Code
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