K-number	K132829
Device name	QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
Applicant	Maquet Cardiopulmonary, AG
Product code	DTZ
Device class	Class II
Decision date	Oct 8, 2013
Decision	Substantially Equivalent
Regulation	870.4350

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View the full FDA submission: accessdata.fda.gov

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QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS

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