510(k) DEN170055
- Device
- Retrograde Intubation Set
- Applicant
- Cook Incorporated
- 510(k) number
- DEN170055
- Product code
- QCX
- Decision
- Unknown (DENG)
- Decision date
- 2018-12-12
- Date received
- 2017-09-25
- Regulation
- 868.5095
- Classification name
- Retrograde Intubation Set
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hui Ouyang
- Address
- 750 Daniels Way Bloomington ID US 47404 47404
FDA Registration Numbers#
- 1000393132
- 1820334
Source Documents#
510(k) summary PDF not indicated by FDA