K-number	K070159
Device name	PRELUDE SHEATH INTRODUCER
Applicant	Merit Medical Systems, Inc.
Product code	DRE
Device class	Class II
Decision date	Jun 21, 2007
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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PRELUDE SHEATH INTRODUCER

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