510(k) K974048 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
| Applicant | Hollister, Inc., Libertyville IL, US |
| Decision | Substantially Equivalent, Dec 23, 1997 |
| Received | Oct 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974048
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.