K-number	K200815
Device name	VitriGuard
Applicant	Origio A/S
Product code	MQK
Device class	Class II
Decision date	Jun 25, 2020
Decision	Substantially Equivalent
Regulation	884.6160

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Source

View the full FDA submission: accessdata.fda.gov

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VitriGuard

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