K-number	K203670
Device name	Extra Large Check-Flo Introducer
Applicant	Cook Incorporated
Product code	DYB
Device class	Class II
Decision date	Feb 16, 2021
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Extra Large Check-Flo Introducer

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