K-number	K051468
Device name	INNER-LOCK INTRODUCER SHEATH
Applicant	Rex Medical
Product code	DYB
Device class	Class II
Decision date	Aug 4, 2005
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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INNER-LOCK INTRODUCER SHEATH

Everything you need for a 510(k) submission. Nothing you don't.