Name: Predicase
Price: 199 USD

K-number	DEN190042
Device name	Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
Applicant	Baxter Healthcare Corporation
Product code	QAX
Device class	Class II
Decision date	Aug 28, 2020
Decision	Not Substantially Equivalent
Regulation	876.5862

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Source

View the full FDA submission: accessdata.fda.gov

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Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer

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