The following data is part of a premarket notification filed by Medinol Ltd. with the FDA for Nir Biliary Stent.
| Device ID | K973171 |
| 510k Number | K973171 |
| 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 | Tami Abudi |
| Correspondent | Tami Abudi 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 | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1998-11-13 |
| Summary: | summary |