510(k) K964968 ยท FPA Set, Administration, Intravascular
MR EXTENSION SET (001)
| Applicant | University of Michigan, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Feb 27, 1997 |
| Received | Dec 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964968
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.