510(k) K210864 ยท FMI Needle, Hypodermic, Single Lumen
Safety Pen Needle
| Applicant | Sandstone Medical (Suzhou), Inc., Suzhou, CN |
| Decision | Substantially Equivalent, Feb 17, 2022 |
| Received | Mar 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210864
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.