510(k) DEN150011 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Sonablate 450
| Applicant | Sonacare Medical, LLC, Charlotte NC, US |
| Decision | Unknown, Oct 9, 2015 |
| Received | Mar 23, 2015 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN150011
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.