K-number	K142357
Device name	DuraSheath Introducer Sheath System
Applicant	Contract Medical International, GmbH
Product code	DYB
Device class	Class II
Decision date	Jun 25, 2015
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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DuraSheath Introducer Sheath System

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