510(k) K854580 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
| Applicant | Coloplast A/S, Fort Woth TX, US |
| Decision | Substantially Equivalent, Dec 13, 1985 |
| Received | Nov 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854580
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.