Name: Predicase
Price: 199 USD

K-number	K192283
Device name	MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
Applicant	Medron, LLC
Product code	DRE
Device class	Class II
Decision date	May 6, 2020
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator

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