Name: Predicase
Price: 199 USD

K-number	K222284
Device name	Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
Applicant	Applied Medical Resources Corporation
Product code	GEI
Device class	Class II
Decision date	Oct 14, 2022
Decision	Substantially Equivalent
Regulation	878.4400

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)

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