| K-number | K150263 |
| Device name | K-Pack II Needle-21G x 2 |
| Applicant | Terumo Europe N.V. |
| Product code | FMI |
| Device class | Class II |
| Decision date | Apr 1, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 880.5570 |
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