Name: Predicase
Price: 199 USD

K-number	K082117
Device name	QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
Applicant	Maquet Cardiopulmonary, AG
Product code	DTZ
Device class	Class II
Decision date	Feb 18, 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 ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000

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