K-number	K152044
Device name	Flexor Radial Hydrophilic Introducer Access Set
Applicant	Cook Incorporated
Product code	DYB
Device class	Class II
Decision date	Aug 14, 2015
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Flexor Radial Hydrophilic Introducer Access Set

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