K-number	K171206
Device name	D'Vill Introducer
Applicant	NuMED, Inc.
Product code	DYB
Device class	Class II
Decision date	Oct 20, 2017
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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D'Vill Introducer

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