510(k) K151398 ยท FMI Needle, Hypodermic, Single Lumen
K-Pack II Needle - 29G x 5/16 Thin Wall
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Jun 25, 2015 |
| Received | May 26, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151398
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.