K-number	K954713
Device name	DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
Applicant	Ideas For Medicine, Inc.
Product code	FGE
Device class	Class II
Decision date	Jul 24, 1996
Decision	Substantially Equivalent
Regulation	876.5010

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View the full FDA submission: accessdata.fda.gov

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DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)

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