K160799 is an FDA 510(k) clearance for the GenNarino. 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 February 17, 2017, 331 days after receiving the submission on March 23, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5560.
| 510(k) Number | K160799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2016 |
| Decision Date | February 17, 2017 |
| Days to Decision | 331 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 |