K-number	K172588
Device name	Balloon Catheter and Balloon Ureteral Dilator Set
Applicant	Cook Incorporated
Product code	EZN
Device class	Class II
Decision date	Apr 19, 2018
Decision	Unknown
Regulation	876.5470

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Source

View the full FDA submission: accessdata.fda.gov

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Balloon Catheter and Balloon Ureteral Dilator Set

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