K232917
- 510(k) number
- K232917
- Device name
- Chemo Mouthpiece
- Applicant
- Chemo Mouthpiece, LLC NJ · US
- Product code
- QUA — Intraoral Cooling Device
- Decision date
- 2024-01-23
- Date received
- 2023-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232917.pdf
Official FDA record: K232917
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.