510(k) K260855 · FMI Needle, Hypodermic, Single Lumen
Profoject Safety Pen Needles
| Applicant | CMT Health PTE., Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Jun 10, 2026 |
| Received | Mar 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260855
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.