510(k) K232063
K232063 is an FDA 510(k) premarket notification submitted by Saliwell , Ltd. for the device "SaliPen". The FDA issued a decision of Substantially Equivalent on December 13, 2023. The device falls under product code QTT (Over The Counter Electrical Salivary Stimulatory System), a Class II device regulated under 21 CFR 872.5560. Saliwell , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2023
- Date Received
- July 11, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over The Counter Electrical Salivary Stimulatory System
- Device Class
- Class II
- Regulation Number
- 872.5560
- Review Panel
- DE
- Submission Type
Over the Counter Device intended to electrically stimulate a relative increase in saliva production