K232063
- 510(k) number
- K232063
- Device name
- SaliPen
- Applicant
- Saliwell , Ltd. IL
- Product code
- QTT — Over The Counter Electrical Salivary Stimulatory Sys
- Decision date
- 2023-12-13
- Date received
- 2023-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K232063.pdf
Official FDA record: K232063
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.