510(k) K172721 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
FOCAL ONE
| Applicant | Edap Technomed, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jun 7, 2018 |
| Received | Sep 8, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172721
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.