K-number	K142819
Device name	Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
Applicant	Cook Incorporated
Product code	DYB
Device class	Class II
Decision date	Jul 24, 2015
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set

Everything you need for a 510(k) submission. Nothing you don't.