K-number	K093232
Device name	OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER
Applicant	Great Batch Medical
Product code	DYB
Device class	Class II
Decision date	Mar 15, 2010
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER

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