Phagenyx System
FDA 510(k) clearance DEN220025 · decided 2022-09-16
Clearance details
- K-number
- DEN220025
- Device name
- Phagenyx System
- Applicant
- Phagenesis Limited
- Decision
- Unknown
- Date received
- 2022-04-19
- Decision date
- 2022-09-16
- Days to decision
- 150 days
- Clearance type
- Direct
- Product code
- QQG
- Device class
- 2
- Regulation number
- 874.5950
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Manchester, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.