Name: Predicase
Price: 199 USD

K-number	K962309
Device name	ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
Applicant	Althin Medical AB an Affiliate of Baxter Intl
Product code	FJI
Device class	Class II
Decision date	Dec 27, 1996
Decision	Substantially Equivalent
Regulation	876.5820

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View the full FDA submission: accessdata.fda.gov

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ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS

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