| DeNovo ID | DEN160037 |
| Device Name: | DermaPACE System |
| Classification | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Applicant | SANUWAVE, INC. 11475 Great Oaks Way, Ste 150 Alpharetta, GA 30022 |
| Contact | Peter Stegagno |
| Product Code | PZL |
| CFR Regulation Number | 878.4685 [🔎] |
| 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 | 2016-07-25 |
| Decision Date | 2017-12-28 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |