510(k) DEN220025
- Device
- Phagenyx System
- Applicant
- Phagenesis Limited
- 510(k) number
- DEN220025
- Product code
- QQG
- Decision
- Unknown (DENG)
- Decision date
- 2022-09-16
- Date received
- 2022-04-19
- Regulation
- 874.5950
- Classification name
- Oropharyngeal Electrical Stimulator
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Conor Mulrooney
- Address
- Unit 18, Enterprise House Pencroft Ay, Manchester Science Park Manchester GB M15 65E M15 65E
FDA Registration Numbers#
- 3010155661
- 3002806730
- 3014265054
Source Documents#
510(k) summary PDF not indicated by FDA