K-number	K203241
Device name	OmniGuide BeamPath OTO-U Fiber
Applicant	Omniguide, Inc.
Product code	GEX
Device class	Class II
Decision date	Jan 14, 2021
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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OmniGuide BeamPath OTO-U Fiber

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