K-number	K161770
Device name	Rusch Silicone Foley Catheter
Applicant	Teleflexmedical, Inc.
Product code	EZL
Device class	Class II
Decision date	May 5, 2017
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Rusch Silicone Foley Catheter

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