510(k) K090117 ยท FMI Needle, Hypodermic, Single Lumen
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET
| Applicant | Autosafe-Reflex, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Sep 29, 2009 |
| Received | Jan 21, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K090117
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.