510(k) K220618
K220618 is an FDA 510(k) premarket notification submitted by Saliwell , Ltd. for the device "SaliPen". The FDA issued a decision of Substantially Equivalent on August 30, 2022. 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
- August 30, 2022
- Date Received
- March 3, 2022
- 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