510(k) K010647 ยท FPA Set, Administration, Intravascular
SIMPLICITY INFUSER INFUSION SET
| Applicant | Sterling Medivations, Inc., Wayzata MN, US |
| Decision | Substantially Equivalent, Apr 13, 2001 |
| Received | Mar 5, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010647
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.