510(k) K063504 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
ECONOLITH EM1000
| Applicant | Medispec, Ltd., Germantown MD, US |
| Decision | Substantially Equivalent, Mar 9, 2007 |
| Received | Nov 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063504
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.