Name: Predicase
Price: 199 USD

K-number	K022450
Device name	INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
Applicant	Dideco S.P.A.
Product code	DTZ
Device class	Class II
Decision date	Oct 22, 2002
Decision	Substantially Equivalent
Regulation	870.4350

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View the full FDA submission: accessdata.fda.gov

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INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY

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