Name: Predicase
Price: 199 USD

K-number	K952343
Device name	FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
Applicant	National Medical Care, Medical Products Div., Inc.
Product code	FJI
Device class	Class II
Decision date	Dec 22, 1995
Decision	Substantially Equivalent
Regulation	876.5820

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Source

View the full FDA submission: accessdata.fda.gov

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FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER

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