The Cooral System
FDA 510(k) clearance DEN210027 · decided 2022-10-14
Clearance details
- K-number
- DEN210027
- Device name
- The Cooral System
- Applicant
- Braincool AB
- Decision
- Unknown
- Date received
- 2021-07-02
- Decision date
- 2022-10-14
- Days to decision
- 469 days
- Clearance type
- Direct
- Product code
- QUA
- Device class
- 2
- Regulation number
- 872.5590
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lund, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Chemo Mouthpiece (K232917) | Chemo Mouthpiece, LLC | 2024-01-23 |
Recalls involving this device
No recalls on record reference this clearance.