Name: Predicase
Price: 199 USD

K-number	K100278
Device name	QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
Applicant	Maquet Cardiopulmonary, AG
Product code	DTZ
Device class	Class II
Decision date	Apr 30, 2010
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA

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