510(k) K121833 ยท EXD Irrigator, Ostomy
OSTOMY IRRIGATION SET
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Jul 16, 2012 |
| Received | Jun 22, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121833
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.