K-number	DEN170055
Device name	Retrograde Intubation Set
Applicant	Cook Incorporated
Product code	QCX
Device class	Class II
Decision date	Dec 12, 2018
Decision	Not Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Retrograde Intubation Set

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