K-number	K180345
Device name	Uroject12 Syringe Lever
Applicant	Urogen Pharma, Ltd.
Product code	QBL
Device class	Class II
Decision date	Oct 17, 2018
Decision	Substantially Equivalent
Regulation	880.5860

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View the full FDA submission: accessdata.fda.gov

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Uroject12 Syringe Lever

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