Name: Predicase
Price: 199 USD

K-number	K143538
Device name	MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
Applicant	Bayer Medical Care, Inc.
Product code	DXT
Device class	Class II
Decision date	Aug 14, 2015
Decision	Substantially Equivalent
Regulation	870.1650

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Source

View the full FDA submission: accessdata.fda.gov

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MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit

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