510(k) K011106 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
STONELITH, MODEL V5
| Applicant | Pck Electronic Industry and Trade Co, Ltd., Ankara, TR |
| Decision | Substantially Equivalent, Feb 11, 2002 |
| Received | Apr 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011106
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.