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 |