The following data is part of a premarket notification filed by Alveolus, Inc. with the FDA for Alveolus, Tb-sts Tracheobronchial Stent System.
| Device ID | K033053 |
| 510k Number | K033053 |
| Device Name: | ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | ALVEOLUS, INC. 9013 PERIMETER WOODS SUITE A Charlotte, NC 28216 |
| Contact | Howard Schrayer |
| Correspondent | Howard Schrayer ALVEOLUS, INC. 9013 PERIMETER WOODS SUITE A Charlotte, NC 28216 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-02-25 |
| Summary: | summary |