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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
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