510(k) DEN160037 ยท PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
dermaPACE System
| Applicant | Sanuwave, Inc., Alpharetta GA, US |
| Decision | Unknown, Dec 28, 2017 |
| Received | Jul 25, 2016 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN160037
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.