Name: Predicase
Price: 199 USD

K-number	K232955
Device name	Numen Coil Embolization System; NumenFR Detachment System
Applicant	MicroPort NeuroTech (Shanghai) Co., Ltd.
Product code	HCG
Device class	Class II
Decision date	Jan 10, 2024
Decision	Substantially Equivalent
Regulation	882.5950

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Source

View the full FDA submission: accessdata.fda.gov

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Numen Coil Embolization System; NumenFR Detachment System

Everything you need for a 510(k) submission. Nothing you don't.