510(k) K023535 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
TRIPTER X-1 COMPACT DUET
| Applicant | Direx Systems Corp., Natick MA, US |
| Decision | Substantially Equivalent, Jan 17, 2003 |
| Received | Oct 21, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023535
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.