Name: Predicase
Price: 199 USD

K-number	K003571
Device name	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
Applicant	Terumo Medical Corp.
Product code	FMF
Device class	Class II
Decision date	Feb 12, 2001
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE

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