The following data is part of a premarket notification filed by Alveolus, Inc. with the FDA for Alimaxx-b Uncovered Biliary Stent System.
| Device ID | K072720 |
| 510k Number | K072720 |
| Device Name: | ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ALVEOLUS, INC. 9013 PERIMETER WOODS DRIVE SUITE A Charlotte, NC 28216 |
| Contact | Tony D Alexander |
| Correspondent | Tony D Alexander ALVEOLUS, INC. 9013 PERIMETER WOODS DRIVE SUITE A Charlotte, NC 28216 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-25 |
| Decision Date | 2008-04-11 |
| Summary: | summary |