510(k) K121656 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
GEMINI LITHOTRIPTER
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Sep 24, 2012 |
| Received | Jun 5, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121656
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.