K-number	K080708
Device name	VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
Applicant	Gish Biomedical, Inc.
Product code	DTZ
Device class	Class II
Decision date	Feb 2, 2009
Decision	Substantially Equivalent
Regulation	870.4350

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View the full FDA submission: accessdata.fda.gov

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VISION HOLLOW FIBER OXYGENATOR WITH HA COATING

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