510(k) K934895 ยท EZL Catheter, Retention Type, Balloon
GLASSMAN SILICONE CATHETER
| Applicant | Axiom Medical, Inc., Rancho Dominguez CA, US |
| Decision | Substantially Equivalent, Oct 13, 1994 |
| Received | Oct 5, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934895
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.