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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K200402
Device Name DR-HO'S Electro Therapy Conductive Gel
Applicant
Guangzhou Xinbo Electronic Co., Ltd.
23 Bldg., Phase-Ii, Huachuang Industry Park, Panyu,
Guangzhou,China.
Guangzhou,  CN 511450
Applicant Contact Sammy Li
Correspondent
Guangzhou Glomed Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.
Huangpu District
Guangzhou,  CN 510700
Correspondent Contact Cassie Lee
Regulation Number882.1275
Classification Product Code
GYB  
Date Received02/19/2020
Decision Date 11/25/2020
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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