Name: Predicase
Price: 199 USD

K-number	K152361
Device name	OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
Applicant	Liebel-Flarsheim Company, LLC
Product code	IZQ
Device class	Class II
Decision date	Jan 14, 2016
Decision	Substantially Equivalent
Regulation	870.1650

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Source

View the full FDA submission: accessdata.fda.gov

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OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System

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