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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, cutaneous
510(k) Number K171722
Device Name Electrodes with snap / Electrodes with pigtail
Shenzhen Konmed Technology Co., Ltd
703B, Haide building A, Nanxin Road, Nanshan
Shenzhen,  CN 518000
Applicant Contact Tony Tony
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, No.121 Science Road
Guangzhou Science Park
Guangzhou,  CN 510006
Correspondent Contact Cecilia Ceng
Regulation Number882.1320
Classification Product Code
Date Received06/12/2017
Decision Date 01/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No