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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K221694
Device Name External Drainage System
Applicant
Jmed(Shenzhen) Technology Limited
7#401, Zhongxing Rd., Xiuxin Community,
Kengzi St., Pingshan District
Shenzhen City,  CN 518122
Applicant Contact Anna Xiao
Correspondent
Jmed(Shenzhen) Technology Limited
7#401, Zhongxing Rd., Xiuxin Community,
Kengzi St., Pingshan District
Shenzhen City,  CN 518122
Correspondent Contact Anna Xiao
Regulation Number882.5550
Classification Product Code
JXG  
Date Received06/10/2022
Decision Date 02/09/2023
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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