Name: Predicase
Price: 199 USD

K-number	K070264
Device name	50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
Applicant	Terumo Europe N.V.
Product code	FMF
Device class	Class II
Decision date	May 29, 2007
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB

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