510(k) K053007 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
SKYLARK URO PROBE
| Applicant | Skylark Device & Systems Co., Ltd., Taipei, TW |
| Decision | Substantially Equivalent, Dec 5, 2005 |
| Received | Oct 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053007
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.