510(k) K915246 ยท EXI Device, Paste-On For Incontinence, Sterile
CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
| Applicant | Coloplast A/S, Fort Woth TX, US |
| Decision | Substantially Equivalent, Feb 5, 1992 |
| Received | Nov 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915246
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.