Name: Predicase
Price: 199 USD

K-number	K010268
Device name	FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
Applicant	Fresenius Medical Care North America
Product code	KOC
Device class	Class II
Decision date	Apr 27, 2001
Decision	Substantially Equivalent
Regulation	876.5820

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Source

View the full FDA submission: accessdata.fda.gov

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FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9

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