510(k) K955439 ยท GBX Catheter, Irrigation
THE REEL THING (MODIFICATION)
| Applicant | Biomedical Devices, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 26, 1995 |
| Received | Nov 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955439
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.