510(k) K840268 ยท EXD Irrigator, Ostomy
IRRIGATION SYSTEM
| Applicant | Coloplast A/S, Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 5, 1984 |
| Received | Jan 23, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840268
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.