510(k) K050770 ยท MEB Pump, Infusion, Elastomeric
MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
| Applicant | Mckinley Medical, LLC, Wheat Ridge CO, US |
| Decision | Substantially Equivalent, Apr 14, 2005 |
| Received | Mar 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050770
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.