The following data is part of a premarket notification filed by Alveolus, Inc. with the FDA for Aleolus/enoventions,alimaxx-e Dv Esophageal Stent System.
| Device ID | K060239 |
| 510k Number | K060239 |
| Device Name: | ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM |
| Classification | Prosthesis, Esophageal |
| Applicant | ALVEOLUS, INC. 9013 PERIMETER WOODS SUITE A Charlotte, NC 28216 |
| Contact | Don Canal |
| Correspondent | Don Canal ALVEOLUS, INC. 9013 PERIMETER WOODS SUITE A Charlotte, NC 28216 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-31 |
| Decision Date | 2006-03-22 |
| Summary: | summary |