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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transcutaneous Nerve Stimulator For Adhd
510(k) Number K213629
Device Name SMILE
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 Number882.5898
Classification Product Code
QGL  
Date Received11/17/2021
Decision Date 02/12/2023
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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