The following data is part of a premarket notification filed by Alveolus, Inc. with the FDA for Aero Tracheobronchial Stent System, Model 90129-2xx.
| Device ID | K062511 |
| 510k Number | K062511 |
| Device Name: | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | ALVEOLUS, INC. 9013 PERIMETER WOODS DRIVE SUITE A Charlotte, NC 28216 |
| Contact | Donald Canal |
| Correspondent | Donald Canal ALVEOLUS, INC. 9013 PERIMETER WOODS DRIVE SUITE A Charlotte, NC 28216 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2007-01-31 |
| Summary: | summary |