K-number	K091767
Device name	3 WAY SILICONE FOLEY BALLOON CATHETER
Applicant	Cook Urological, Inc.
Product code	EZL
Device class	Class II
Decision date	Oct 9, 2009
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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3 WAY SILICONE FOLEY BALLOON CATHETER

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