510(k) K964738 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
ELPHA 2000 CONTI
| Applicant | Dan Med, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Aug 14, 1997 |
| Received | Nov 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964738
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.