510(k) K946243 ยท EXJ Device, Incontinence, Urosheath Type, Sterile
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
| Applicant | Coloplast A/S, Marietta GA, US |
| Decision | Substantially Equivalent, Feb 13, 1995 |
| Received | Dec 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946243
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.