FDA Product Code
FDA Product Code QUA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5590
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | 2024-01-23 | Traditional | PDF ↗ |
| DEN210027 | The Cooral System | Braincool AB | 2022-10-14 | Direct | — |
Product code QUA · Class II · Dental. Data: openFDA.