Name: Predicase
Price: 199 USD

K-number	K024126
Device name	CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
Applicant	Abbott Laboratories
Product code	DQO
Device class	Class II
Decision date	Jan 14, 2003
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT

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