K-number	DEN130044
Device name	INFLOW INTRAURETHRAL VALVE-PUMP
Applicant	Vesiflo, Inc.
Product code	PIH
Device class	Class II
Decision date	Oct 14, 2014
Decision	Not Substantially Equivalent
Regulation	876.5140

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Source

View the full FDA submission: accessdata.fda.gov

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INFLOW INTRAURETHRAL VALVE-PUMP

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