K-number	K182709
Device name	One-Step Suprapubic Introducer
Applicant	Cook Incorporated
Product code	KOB
Device class	Class II
Decision date	Dec 26, 2018
Decision	Substantially Equivalent
Regulation	876.5090

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Source

View the full FDA submission: accessdata.fda.gov

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One-Step Suprapubic Introducer

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