510(k) K161255 ยท FMI Needle, Hypodermic, Single Lumen
meso-relle (AAL34, AAL36, AM30G)
| Applicant | Biotekne Srl, Casalecchio Di Reno, IT |
| Decision | Substantially Equivalent, Jan 19, 2017 |
| Received | May 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161255
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.