510(k) K131954 ยท FMI Needle, Hypodermic, Single Lumen
MEDI PEN NEEDLE
| Applicant | Shanghai Carelife International Trading Co. , Ltd., Shanghai, Pudong, CN |
| Decision | Substantially Equivalent, May 29, 2014 |
| Received | Jun 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131954
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.