510(k) K964575 ยท EZL Catheter, Retention Type, Balloon
SYMPACATH HYDROGEL COATED FOLEY
| Applicant | Rusch Intl., Jeffrey NH, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Nov 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964575
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.