K-number	K190987
Device name	Uroject12 Syringe Lever
Applicant	Urogen Pharma, Ltd.
Product code	QBL
Device class	Class II
Decision date	Dec 2, 2019
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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Uroject12 Syringe Lever

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