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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 K213879
Device Name Self-adhesive Electrode
Applicant
Bozhou Rongjian Medical Appliance Co., Ltd.
Jianghuai Supply Base, Zhongkai Group, Mengcheng County
Bozhou,  CN 233500
Applicant Contact Zhifang Wu
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 903, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/13/2021
Decision Date 01/05/2022
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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