510(k) K041582 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
MODIFICATION TO TRIPTER X-1 COMPACT DUET
| Applicant | Direx Systems Corp., Natick MA, US |
| Decision | Substantially Equivalent, Jul 7, 2004 |
| Received | Jun 14, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041582
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.