510(k) K012785 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
TWINTRODE ELC 134 ELECTRODE
| Applicant | Healthtronics Surgical Services, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Nov 16, 2001 |
| Received | Aug 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012785
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.