Name: Predicase
Price: 199 USD

K-number	K040255
Device name	POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
Applicant	Gambro Renal Products, Inc.
Product code	KDI
Device class	Class II
Decision date	May 24, 2004
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE

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