Name: Predicase
Price: 199 USD

K-number	K101715
Device name	FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
Applicant	Fresenius Medical Care North America, Design Cente
Product code	KDI
Device class	Class II
Decision date	Dec 21, 2010
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

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