K180838 is an FDA 510(k) clearance for the SaliPen. This device is classified as a Stimulator, Salivary System (Class II - Special Controls, product code LTF).
Submitted by Saliwell , Ltd. (Harutzim, IL). The FDA issued a Cleared decision on November 6, 2018, 221 days after receiving the submission on March 30, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5560.
| 510(k) Number | K180838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2018 |
| Decision Date | November 06, 2018 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LTF - Stimulator, Salivary System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5560 |