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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, neurovascular embolization
510(k) Number K232955
Device Name Numen Coil Embolization System; NumenFR Detachment System
Applicant
MicroPort NeuroTech (Shanghai) Co., Ltd.
16th Building , 222 Guangdan Road, Pudong New District
Shanghai,  CN 201318
Applicant Contact Jiayin Sun
Correspondent
BioDesign Regulatory Services, LLC
16185 Los Gatos Blvd, Suite 205
Los Gatos,  CA  95032
Correspondent Contact Ivory Chang
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received09/21/2023
Decision Date 01/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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