510(k) K160942 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Sonablate
| Applicant | Sonacare Medical, LLC, Charlotte NC, US |
| Decision | Substantially Equivalent, Dec 21, 2016 |
| Received | Apr 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160942
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.