K-number	K212448
Device name	NightGuard Flex
Applicant	Sprintray, Inc.
Product code	MQC
Device class	Class U
Decision date	Nov 12, 2021
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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NightGuard Flex

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