510(k) K863830 ยท EZQ Pouch, Colostomy
CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM
| Applicant | Coloplast A/S, Fort Woth TX, US |
| Decision | Substantially Equivalent, Oct 16, 1986 |
| Received | Sep 30, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863830
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.