K-number	K905042
Device name	COMFORT SLEEVED ALL SILICONE FOLEY CATHETER
Applicant	Rochester Medical Corp.
Product code	EZL
Device class	Class II
Decision date	Jan 18, 1991
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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COMFORT SLEEVED ALL SILICONE FOLEY CATHETER

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