Retrograde Intubation Set

Tube, Tracheal (w/wo Connector)

Cook Incorporated

The following data is part of a De Novo classification by Cook Incorporated with the FDA for Retrograde Intubation Set.

Pre-market Notification Details

DeNovo IDDEN170055
Device Name:Retrograde Intubation Set
ClassificationTube, Tracheal (w/wo Connector)
Applicant Cook Incorporated 750 Daniels Way Bloomington,  ID  47404
ContactHui Ouyang
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardAnesthesiology
Classification AdvisoryAnesthesiology
TypeDirect
Date Received2017-09-25
Decision Date2018-12-12
Reclassification Order:Reclassification Order

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