The following data is part of a premarket notification filed by Medinol Ltd. with the FDA for Medinol X-suit Nir Biliary Metallic Stent.
| Device ID | K081956 |
| 510k Number | K081956 |
| Device Name: | MEDINOL X-SUIT NIR BILIARY METALLIC STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDINOL LTD. 386 WEST MAIN STREET SUITE 7 Northboro, MA 01532 |
| Contact | Leo L Basta |
| Correspondent | Leo L Basta MEDINOL LTD. 386 WEST MAIN STREET SUITE 7 Northboro, MA 01532 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-09 |
| Decision Date | 2009-01-09 |
| Summary: | summary |