510(k) K230070 · FMI Needle, Hypodermic, Single Lumen
MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESO
| Applicant | Promamedical, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Oct 5, 2023 |
| Received | Jan 10, 2023 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K230070
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.