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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 K192773
Device Name ALLIVE
Applicant
Nu Eyne Co., Ltd
#403, Seoul Biohub, 117-3 Hoegi-ro, Dongdaemun-gu
Seoul,  KR 02455
Applicant Contact Dong Seong Lee
Correspondent
KMC, Inc.
Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu
Seoul,  KR 08375
Correspondent Contact DongHa Lee
Regulation Number882.5891
Classification Product Code
PCC  
Date Received09/30/2019
Decision Date 12/06/2019
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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