510(k) K232063
- Device
- SaliPen
- Applicant
- Saliwell , Ltd.
- 510(k) number
- K232063
- Product code
- QTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-13
- Date received
- 2023-07-11
- Regulation
- 872.5560
- Classification name
- Over The Counter Electrical Salivary Stimulatory System
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ben Z. Beiski
- Address
- 3a Hatamar St. Harutzim IL 6091700 6091700
FDA Registration Numbers#
- 3015282800
Source Documents#
Other 510(k) Records For Product Code QTT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220618 | SaliPen | Saliwell , Ltd. | 2022-08-30 |