510(k) K252631 · FMI Needle, Hypodermic, Single Lumen
Profoject Disposable Needle
| Applicant | CMT Health PTE., Ltd., Gateway W., SG |
| Decision | Substantially Equivalent, Oct 16, 2025 |
| Received | Aug 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252631
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.