Name: Predicase
Price: 199 USD

K-number	K131641
Device name	MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
Applicant	Nipro Medical Corporation
Product code	FMF
Device class	Class II
Decision date	Aug 28, 2013
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)

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