K-number	K230495
Device name	Serena Sleep Night Guard
Applicant	Meris Investment Group
Product code	MQC
Device class	Class U
Decision date	Oct 13, 2023
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Serena Sleep Night Guard

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