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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, Transcutaneous, Over-The-Counter
510(k) Number K172451
Device Name Dr.MUSIC 3s
Applicant
Smartmedicaldevice Co., Ltd.
32-19, Gobong-Ro, Ilsandong-Gu
Goyang-Si,  KR 10364
Applicant Contact Dong-Min Lee
Correspondent
The Allis Law Firm, Pllc
2437 Bay Area Blvd. #30
Houston,  TX  77058
Correspondent Contact Carmelina G. Allis
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received08/14/2017
Decision Date 11/17/2017
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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