SaliPen
Stimulator, Salivary System
Saliwell Ltd.
The following data is part of a premarket notification filed by Saliwell Ltd. with the FDA for Salipen.
Pre-market Notification Details
| Device ID | K180838 |
| 510k Number | K180838 |
| Device Name: | SaliPen |
| 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 | 2018-03-30 |
| Decision Date | 2018-11-06 |
| Summary: | summary |
Trademark Results [SaliPen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SALIPEN 90794129 not registered Live/Pending |
Dr. Andy Wolff 2021-06-24 |
SALIPEN 90794129 not registered Live/Pending |
Eng. Ben Z. Beiski 2021-06-24 |
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