Name: Predicase
Price: 199 USD

K-number	K871236
Device name	HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H
Applicant	National Medical Care, Medical Products Div., Inc.
Product code	FJI
Device class	Class II
Decision date	May 29, 1987
Decision	Substantially Equivalent
Regulation	876.5820

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Source

View the full FDA submission: accessdata.fda.gov

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HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H

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