510(k) K881636 ยท EXB Collector, Ostomy
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
| Applicant | Coloplast A/S, Fort Woth TX, US |
| Decision | Substantially Equivalent, Jul 13, 1988 |
| Received | Apr 14, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881636
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.