The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Luminexx Endoscopic Biliary Stent.
| Device ID | K031186 |
| 510k Number | K031186 |
| Device Name: | LUMINEXX ENDOSCOPIC BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821 |
| Contact | Thomas Hirte |
| Correspondent | Thomas Hirte C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-15 |
| Decision Date | 2003-05-06 |
| Summary: | summary |