Name: Predicase
Price: 199 USD

K-number	K152913
Device name	GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
Applicant	Creganna Medical Aslo Business AS Cregganna Tactx Medical
Product code	DYB
Device class	Class II
Decision date	Jul 21, 2016
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

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