510(k) K030039 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
PATHWAY STM-10 PELVIC FLOOR STIMULATOR
| Applicant | The Prometheus Group, Duxbury MA, US |
| Decision | Substantially Equivalent, May 23, 2003 |
| Received | Jan 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030039
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.