510(k) K180838
- Device
- SaliPen
- Applicant
- Saliwell Ltd.
- 510(k) number
- K180838
- Product code
- LTF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-06
- Date received
- 2018-03-30
- Regulation
- 872.5560
- Classification name
- Stimulator, Salivary 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
- 65 Hatamar St. Harutzim IL 6091700 6091700
FDA Registration Numbers#
- 3015282800
Source Documents#
Legacy Summary#
summary
FDA Review#
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