Name: Predicase
Price: 199 USD

K-number	K222741
Device name	DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
Applicant	Hdi, Inc.
Product code	ELW
Device class	Class II
Decision date	Nov 7, 2022
Decision	Substantially Equivalent
Regulation	872.3660

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

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