510(k) K965146 ยท GBX Catheter, Irrigation
FLAT CLOSED WOUND DRAIN WITH TROCAR
| Applicant | Axiom Medical, Inc., Rancho Dominguez CA, US |
| Decision | Substantially Equivalent, Mar 10, 1997 |
| Received | Dec 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965146
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.