K-number	K211035
Device name	U9000 Plus Ultrafilter
Applicant	Baxter Healthcare Corporation
Product code	FIP
Device class	Class II
Decision date	Oct 19, 2021
Decision	Substantially Equivalent
Regulation	876.5665

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Source

View the full FDA submission: accessdata.fda.gov

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U9000 Plus Ultrafilter

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