Name: Predicase
Price: 199 USD

K-number	K180395
Device name	EZ-IO Intraosseous Vascular Access System
Applicant	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Product code	FMI
Device class	Class II
Decision date	Nov 9, 2018
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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EZ-IO Intraosseous Vascular Access System

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