The following data is part of a premarket notification filed by Saliwell Ltd. with the FDA for Gennarino.
| Device ID | K160799 |
| 510k Number | K160799 |
| Device Name: | GenNarino |
| Classification | Stimulator, Salivary System |
| Applicant | SALIWELL LTD. 65 HATAMAR ST. Harutzim, IL 6091700 |
| Contact | Ben Z. Beiski |
| Correspondent | Ben Z. Beiski SALIWELL LTD. 65 HATAMAR ST. Harutzim, IL 6091700 |
| Product Code | LTF |
| CFR Regulation Number | 872.5560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-23 |
| Decision Date | 2017-02-17 |
| Summary: | summary |