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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 K211380
Device Name Elexir
Applicant
Nu Eyne Co., Ltd.
#608, 28, Digital-ro 30-gil, Guro-gu
Seoul,  KR 08389
Applicant Contact Dong Seong Lee
Correspondent
Nu Eyne Co., Ltd.
#608, 28, Digital-ro 30-gil, Guro-gu
Seoul,  KR 08389
Correspondent Contact Dong Seong Lee
Regulation Number882.5891
Classification Product Code
PCC  
Date Received05/04/2021
Decision Date 07/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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