510(k) K944376 ยท EZL Catheter, Retention Type, Balloon
ORION ALL SILICONE ELASTOMER COATED CATHETER
| Applicant | Regulatory & Marketing Services, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Nov 30, 1994 |
| Received | Sep 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944376
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.