510(k) K982970 ยท EZL Catheter, Retention Type, Balloon
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
| Applicant | Mri Manufacturing and Research, Inc., New Port Riche FL, US |
| Decision | Substantially Equivalent, Oct 28, 1998 |
| Received | Aug 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982970
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.