K-number	K190028
Device name	UNO 30
Applicant	Genadyne Biotechnologies
Product code	OMP
Device class	Class II
Decision date	Jan 15, 2020
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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UNO 30

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