510(k) K192057 · FMI Needle, Hypodermic, Single Lumen
K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Oct 11, 2019 |
| Received | Aug 1, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192057
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.