Name: Predicase
Price: 199 USD

K-number	K060734
Device name	FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)
Applicant	Fresenius Medical Care North America
Product code	LKN
Device class	Class U
Decision date	Sep 5, 2006
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)

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