510(k) K132233 ยท FMI Needle, Hypodermic, Single Lumen
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Sep 6, 2013 |
| Received | Jul 18, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132233
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.