The following data is part of a premarket notification filed by Medinol Ltd. with the FDA for Nir Biliary Stent.
| Device ID | K002130 |
| 510k Number | K002130 |
| Device Name: | NIR BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDINOL LTD. KIRYAT ATIDIM, BUILDING 7 ENTRANCE A, 5TH FL., POB 58165 Tel-aviv, IL 61581 |
| Contact | Nasr Salman |
| Correspondent | Nasr Salman MEDINOL LTD. KIRYAT ATIDIM, BUILDING 7 ENTRANCE A, 5TH FL., POB 58165 Tel-aviv, IL 61581 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-14 |
| Decision Date | 2000-10-30 |