510(k) K971359 ยท MNG External Urethral Occluder, Urinary Incontinence-Control, Female
RESTORE (A.K.A. CAPSURE)
| Applicant | Nebl, Inc., Worcester MA, US |
| Decision | Substantially Equivalent, Nov 14, 1997 |
| Received | Apr 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971359
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.