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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 K242154
Device Name Numen™ Coil Embolization System; NumenFR™ Detachment System
Applicant
MicroPort NeuroTech (Shanghai) Co., Ltd.
Bldg.#16, 222 Guangdan Rd., Pudong New District
Shanghai,  CN 201318
Applicant Contact Yuying Chen
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 Received07/23/2024
Decision Date 09/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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