510(k) K101482 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
EM-9000
| Applicant | Elite Medical, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, Mar 31, 2011 |
| Received | May 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101482
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.