K-number	K153246
Device name	PTFE Super Sheath Introducer 2.1
Applicant	Medcomp (Medical Components, Inc.)
Product code	DYB
Device class	Class II
Decision date	Feb 12, 2016
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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PTFE Super Sheath Introducer 2.1

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