K-number	K850790
Device name	DIAFLEX OCCLUSION BALLOON CATHETER
Applicant	American Edwards Laboratories
Product code	KOD
Device class	Class II
Decision date	Mar 25, 1985
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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DIAFLEX OCCLUSION BALLOON CATHETER

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