The following data is part of a premarket notification filed by Alveolus, Inc. with the FDA for Alveolus Alimaxx-e Esophageal Stent System.
| Device ID | K080838 |
| 510k Number | K080838 |
| Device Name: | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM |
| Classification | Prosthesis, Esophageal |
| 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 | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-25 |
| Decision Date | 2008-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450038595 | K080838 | 000 |
| 10884450030643 | K080838 | 000 |
| 10884450030650 | K080838 | 000 |
| 10884450030667 | K080838 | 000 |
| 10884450030674 | K080838 | 000 |
| 10884450030681 | K080838 | 000 |
| 10884450033507 | K080838 | 000 |
| 10884450033514 | K080838 | 000 |
| 10884450033521 | K080838 | 000 |
| 10884450038540 | K080838 | 000 |
| 10884450038557 | K080838 | 000 |
| 10884450038564 | K080838 | 000 |
| 10884450038571 | K080838 | 000 |
| 10884450038588 | K080838 | 000 |
| 10884450030636 | K080838 | 000 |