510(k) K913524 ยท EXJ Device, Incontinence, Urosheath Type, Sterile
SILICONE MALE EXTERNAL CATHETER
| Applicant | Mentor Corp., Goleta CA, US |
| Decision | Substantially Equivalent, Oct 4, 1991 |
| Received | Aug 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913524
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.