510(k) K994109 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
DETRUSAN 500
| Applicant | Innovamed USA, Inc., Lehigh Acres FL, US |
| Decision | Substantially Equivalent, Aug 3, 2000 |
| Received | Dec 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994109
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.