K-number	K193292
Device name	Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
Applicant	Applied Medical Resources Corp.
Product code	GEI
Device class	Class II
Decision date	Dec 20, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Voyant 5mm Fusion Device, Voyant Maryland Fusion Device

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