510(k) K924407 ยท EXJ Device, Incontinence, Urosheath Type, Sterile
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
| Applicant | Coloplast A/S, Fort Woth TX, US |
| Decision | Substantially Equivalent, Sep 23, 1992 |
| Received | Aug 25, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924407
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.