Name: Predicase
Price: 199 USD

K-number	K231263
Device name	Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
Applicant	Prevest Denpro Limited
Product code	EBF
Device class	Class II
Decision date	Jan 5, 2024
Decision	Substantially Equivalent
Regulation	872.3690

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT

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