Name: Predicase
Price: 199 USD

K-number	K090689
Device name	QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
Applicant	Maquet Cardiopulmonary, AG
Product code	DTZ
Device class	Class II
Decision date	Oct 29, 2009
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000

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