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
- N
Related Records
Applicant Contact
- Contact
- David Yoskowitz
- Address
- 10 Railroad Ave. Closter NJ US 07624 07624
FDA Registration Numbers
- 3014426939
- 3004906872
- 3005977121
- 3015177652
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20860001416750 | Chemo Mouthpiece | CHEMOMOUTHPIECE, LLC | 2024-05-23 |
| 20860001416743 | Chemo Mouthpiece | CHEMOMOUTHPIECE, LLC | 2024-05-23 |
Other 510(k) Records For Product Code QUA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN210027 | The Cooral System | Braincool AB | 2022-10-14 |