Name: Predicase
Price: 199 USD

K-number	K231696
Device name	Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
Applicant	Prevest Denpro Limited
Product code	KLE
Device class	Class II
Decision date	Aug 11, 2023
Decision	Substantially Equivalent
Regulation	872.3200

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal

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