510(k) K053640 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
INTEGRA
| Applicant | Direx Systems Corp., Canton MA, US |
| Decision | Substantially Equivalent, Mar 1, 2006 |
| Received | Dec 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053640
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.