K-number	K130804
Device name	UROMAX ULTRA BALLOON DILATATION CATHETER
Applicant	Boston Scientific Corporation
Product code	EZN
Device class	Class II
Decision date	May 22, 2013
Decision	Substantially Equivalent
Regulation	876.5470

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View the full FDA submission: accessdata.fda.gov

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UROMAX ULTRA BALLOON DILATATION CATHETER

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