510(k) K904586 ยท EXD Irrigator, Ostomy
PALEX IRRIGATION SET
| Applicant | Palex Intl. SA, Spain, ES |
| Decision | Substantially Equivalent, Dec 28, 1990 |
| Received | Oct 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904586
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.