K-number	K150257
Device name	PreludeEASE Hydrophilic Sheath Introducer
Applicant	Merit Medical Systems, Inc.
Product code	DYB
Device class	Class II
Decision date	Jun 19, 2015
Decision	Unknown
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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PreludeEASE Hydrophilic Sheath Introducer

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