K-number	K073434
Device name	BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
Applicant	Bipore, Inc.
Product code	DYB
Device class	Class II
Decision date	Apr 1, 2008
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

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