510(k) K111797 ยท FMI Needle, Hypodermic, Single Lumen
27 G X 1/2 K-PACK SURSHIELD NEEDLE
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Sep 22, 2011 |
| Received | Jun 24, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111797
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.