510(k) K010340 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI
| Applicant | Karl Storz Lithotripsy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Feb 13, 2001 |
| Received | Feb 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010340
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.