510(k) DEN210027
- Device
- The Cooral System
- Applicant
- Braincool AB
- 510(k) number
- DEN210027
- Product code
- QUA
- Decision
- Unknown (DENG)
- Decision date
- 2022-10-14
- Date received
- 2021-07-02
- Regulation
- 872.5590
- Classification name
- Intraoral Cooling Device
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Martin Waleij
- Address
- Scheelevägen 2, Medicon Village Lund SE 22381 22381
FDA Registration Numbers#
- 3015177652
- 3014426939
- 3004906872
- 3005977121
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QUA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | 2024-01-23 |