510(k) K161606 ยท FMF Syringe, Piston
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Feb 10, 2017 |
| Received | Jun 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161606
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.