510(k) K850285 ยท KOD Catheter, Urological
GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY
| Applicant | Premium Plastics, Inc., Elkhorn WI, US |
| Decision | Substantially Equivalent, Feb 28, 1985 |
| Received | Jan 23, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850285
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.