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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 K192568
Device Name Jiajian Self-Adhesive Electrode
Applicant
Wuxi Jiajian Medical Instrument Co., Ltd.
#35 Baiqiao Rd., Ehu Town, Xishan District
Wuxi,  CN 214116
Applicant Contact Caihong Sun
Correspondent
Wuxi Jiajian Medical Instrument Co., Ltd.
#35 Baiqiao Rd., Ehu Town, Xishan District
Wuxi,  CN 214116
Correspondent Contact Caihong Sun
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/18/2019
Decision Date 02/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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