Name: Predicase
Price: 199 USD

K-number	K974812
Device name	COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
Applicant	Cobe Cardiovascular, Inc.
Product code	DTZ
Device class	Class II
Decision date	Jun 1, 1998
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR

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