510(k) K963858 ยท MNG External Urethral Occluder, Urinary Incontinence-Control, Female
FEMASSIST URINARY DEVICE
| Applicant | Insight Medical Corp., Bolton MA, US |
| Decision | Substantially Equivalent, Oct 21, 1997 |
| Received | Sep 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963858
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.