510(k) K063795 ยท GBM Catheter, Urethral
GUARDIANCATHETER-URINARY DRAINAGE CATHETER
| Applicant | Marian Medical, Inc., Louisville KY, US |
| Decision | Substantially Equivalent, Mar 5, 2007 |
| Received | Dec 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063795
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.