Name: Predicase
Price: 199 USD

K-number	K213400
Device name	Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry
Applicant	Rb Health (Us)
Product code	NUC
Device class	Class II
Decision date	Mar 1, 2022
Decision	Substantially Equivalent
Regulation	884.5300

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

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