K-number	K181883
Device name	FIREFLY® Midline Navigation Guide
Applicant	Mighty Oak Medical, Inc.
Product code	PQC
Device class	Class II
Decision date	Oct 3, 2018
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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FIREFLY® Midline Navigation Guide

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