K-number	K162345
Device name	UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
Applicant	Neotract, Inc.
Product code	PEW
Device class	Class II
Decision date	Sep 21, 2016
Decision	Substantially Equivalent
Regulation	876.5530

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View the full FDA submission: accessdata.fda.gov

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UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge

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