510(k) Report

Devices descending from K003571

1 later device reach Serono for Use with Gonal-F 1200IU Multi-Dose Only at 600IU/ML Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161606Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSHTerumo Europe N.V.20170—