Name: Predicase
Price: 199 USD

K-number	K140768
Device name	TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
Applicant	Lepu Medical Technology (Bejing) Co., Ltd.
Product code	DYB
Device class	Class II
Decision date	Nov 25, 2014
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT

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