FDA 510(k) Application Details - DEN170055

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170055
Device Name	Retrograde Intubation Set
Applicant	Cook Incorporated 750 Daniels Way Bloomington, ID 47404 US Other 510(k) Applications for this Company
Contact	Hui Ouyang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2017
Decision Date	12/12/2018
Decision	DENG -
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review