K-number	K990854
Device name	INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
Applicant	Innerdyne, Inc.
Product code	FGE
Device class	Class II
Decision date	Aug 2, 1999
Decision	Substantially Equivalent
Regulation	876.5010

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View the full FDA submission: accessdata.fda.gov

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INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE

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