Name: Predicase
Price: 199 USD

K-number	K093637
Device name	JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300
Applicant	Jms North America Corp.
Product code	FIE
Device class	Class II
Decision date	Feb 9, 2010
Decision	Substantially Equivalent
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300

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