Name: Predicase
Price: 199 USD

K-number	K941225
Device name	UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
Applicant	Baxter Healthcare Corp
Product code	DTZ
Device class	Class II
Decision date	Aug 16, 1994
Decision	Substantially Equivalent
Regulation	870.4350

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View the full FDA submission: accessdata.fda.gov

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UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT

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