510(k) K042561 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
| Applicant | Fmd, LLC, Lorton VA, US |
| Decision | Substantially Equivalent, Oct 12, 2004 |
| Received | Sep 21, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042561
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.