The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Xpert Biliary Stent, Models Ex8l6006, Ex8l3008, Ex8l4008, Ex8l6008, Ex8s6006, Ex8s3008, Ex8s4008, Ex8s6008.
| Device ID | K040667 |
| 510k Number | K040667 |
| Device Name: | XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ABBOTT LABORATORIES 400 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Joanna Kuskowski |
| Correspondent | Joanna Kuskowski ABBOTT LABORATORIES 400 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-15 |
| Decision Date | 2004-04-07 |
| Summary: | summary |