510(k) K110527 ยท FMI Needle, Hypodermic, Single Lumen
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Jun 6, 2011 |
| Received | Feb 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110527
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.