K-number	K101824
Device name	AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
Applicant	Amsino International, Inc.
Product code	EZL
Device class	Class II
Decision date	Sep 13, 2010
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER

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