K-number	K963595
Device name	SERAGARD VASCULAR ACCESS DEVICE
Applicant	Cutting Edge Technologies, Inc.
Product code	FMI
Device class	Class II
Decision date	Jan 6, 1997
Decision	Substantially Equivalent
Regulation	880.5570

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View the full FDA submission: accessdata.fda.gov

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SERAGARD VASCULAR ACCESS DEVICE

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