Name: Predicase
Price: 199 USD

K-number	K043342
Device name	POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
Applicant	Gambro Renal Products
Product code	FJI
Device class	Class II
Decision date	May 27, 2005
Decision	Substantially Equivalent
Regulation	876.5820

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View the full FDA submission: accessdata.fda.gov

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POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

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