K-number	K173657
Device name	Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
Applicant	Cook Incorporated
Product code	EZL
Device class	Class II
Decision date	Aug 23, 2018
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter

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