K-number	K180354
Device name	UroGen Ureteral Catheter
Applicant	Urogen Pharma, Ltd.
Product code	KOD
Device class	Class II
Decision date	Oct 30, 2018
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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UroGen Ureteral Catheter

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