510(k) K170276 ยท FMI Needle, Hypodermic, Single Lumen
Safety Blood Collection Device for Single Use
| Applicant | Gemtier Medical (Shanghai), Inc., Shanghai, CN |
| Decision | Substantially Equivalent, Dec 11, 2017 |
| Received | Jan 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170276
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.