FDA 510(k)

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

Numéro K : K161606 · 2017-02-10

Date de décision2017-02-10

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K161606. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH?

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Terumo Europe N.V.. The 510(k) number is K161606.

When did Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH receive FDA 510(k) clearance?

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH received FDA 510(k) clearance on 2017-02-10, under 510(k) number K161606.

Who is the listed applicant for Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH?

The FDA product code for Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is FMF.

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Source officielle

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