510(k) K980016 ยท MOP Rotator, Prosthetic Heart Valve
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
| Applicant | Genzyme Surgical Product (Genzyme Biosurgery), North Attleboro MA, US |
| Decision | Substantially Equivalent, Aug 7, 1998 |
| Received | Jan 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980016
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.