Name: Predicase
Price: 199 USD

K-number	K192273
Device name	DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
Applicant	DiaDent Group International
Product code	KLE
Device class	Class II
Decision date	Feb 7, 2020
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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DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

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