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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name retrograde intubation set
De Novo Number DEN170055
Device Name Retrograde Intubation Set
Requester
cook incorporated
750 daniels way
bloomington,  ID  47404
Contact hui ouyang
Regulation Number868.5095
Classification Product Code
QCX  
Date Received09/25/2017
Decision Date 12/12/2018
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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