510(k) K193422 ยท FMI Needle, Hypodermic, Single Lumen
Easydrip Pen Needle, Easydrip Plus Pen Needle
| Applicant | Sandstone Medical (Suzhou), Inc., Suzhou, CN |
| Decision | Substantially Equivalent, Feb 2, 2021 |
| Received | Dec 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193422
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.