K-number	K182463
Device name	Silicone Foley Catheter
Applicant	Biosensors International Pte, Ltd.
Product code	EZL
Device class	Class II
Decision date	Nov 6, 2019
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Silicone Foley Catheter

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