510(k) K201074 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Delta III Lithotripter
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Sep 3, 2020 |
| Received | Apr 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201074
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.