Name: Predicase
Price: 199 USD

K-number	K090515
Device name	ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
Applicant	Maquet Cardiopulmonary, AG
Product code	KFM
Device class	Class II
Decision date	Dec 18, 2009
Decision	Substantially Equivalent
Regulation	870.4360

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Source

View the full FDA submission: accessdata.fda.gov

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ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)

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