Name: Predicase
Price: 199 USD

K-number	K151048
Device name	CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
Applicant	Bracco Injeneering
Product code	IZQ
Device class	Class II
Decision date	Jan 22, 2016
Decision	Substantially Equivalent
Regulation	870.1650

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Source

View the full FDA submission: accessdata.fda.gov

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CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set

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