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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K163470
Device Name Galvanic Spa, Model: SKB-1405
Applicant
Shenzhen Siken 3D Technology Development Co., Ltd.
Siken Industrial Park, E. Ave.
#, 33 Songgang St., Baoan District
Shenzhen,  CN
Applicant Contact Kimi Xue
Correspondent
Guangzhou Leta Testing Technology Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Gaungzhou,  CN
Correspondent Contact Jet Li
Regulation Number882.5890
Classification Product Code
NFO  
Date Received12/12/2016
Decision Date 06/02/2017
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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