The following data is part of a De Novo classification by Airxpanders, Inc with the FDA for Aeroform Tissue Expander System.
| DeNovo ID | DEN150055 |
| Device Name: | AeroForm Tissue Expander System |
| Classification | Carbon Dioxide Gas Controlled Tissue Expander |
| Applicant | AIRXPANDERS, INC 1047 Elwell Court Palo Alto, CA 94303 |
| Contact | Robin` Bush |
| Product Code | PQN |
| CFR Regulation Number | 878.3510 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2015-12-07 |
| Decision Date | 2016-12-21 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |