510(k) K232917
- Device
- Chemo Mouthpiece
- Applicant
- Chemo Mouthpiece, LLC
- 510(k) number
- K232917
- Product code
- QUA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-23
- Date received
- 2023-09-19
- Regulation
- 872.5590
- Classification name
- Intraoral Cooling Device
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David Yoskowitz
- Address
- 10 Railroad Ave. Closter NJ US 07624 07624
FDA Registration Numbers#
- 3015177652
- 3014426939
- 3004906872
- 3005977121
Source Documents#
Other 510(k) Records For Product Code QUA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN210027 | The Cooral System | Braincool AB | 2022-10-14 |