Name: Predicase
Price: 199 USD

K-number	K161606
Device name	Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
Applicant	Terumo Europe N.V.
Product code	FMF
Device class	Class II
Decision date	Feb 10, 2017
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.