K-number	K190093
Device name	Rezum Delivery Device, Rezum Generator
Applicant	Nxthera (A Boston Scientific Company)
Product code	KNS
Device class	Class II
Decision date	Mar 25, 2019
Decision	Substantially Equivalent
Regulation	876.4300

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View the full FDA submission: accessdata.fda.gov

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Rezum Delivery Device, Rezum Generator

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