K-number	K211032
Device name	Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
Applicant	Urogen Pharma, Ltd.
Product code	KOD
Device class	Class II
Decision date	Nov 19, 2021
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

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