510(k) K991486 ยท DWZ Device, Biopsy, Endomyocardial
ULTRA-CBX
| Applicant | Medcanica, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Nov 5, 1999 |
| Received | Apr 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991486
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.