510(k) K121458 ยท GBM Catheter, Urethral
SPEEDICATH COMPACT SET (12/18 FR)
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 1, 2012 |
| Received | May 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121458
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.