Chemo Mouthpiece
FDA 510(k) clearance K232917 · decided 2024-01-23
Clearance details
- K-number
- K232917
- Device name
- Chemo Mouthpiece
- Applicant
- Chemo Mouthpiece, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-09-19
- Decision date
- 2024-01-23
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- QUA
- Device class
- 2
- Regulation number
- 872.5590
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Closter, NJ, US
- 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 |
|---|---|---|
| The Cooral System (DEN210027) | Braincool AB | 2022-10-14 |
Recalls involving this device
No recalls on record reference this clearance.