K-number	K930808
Device name	PROTECTOR INTRODUCER SHEATH
Applicant	Boston Scientific /International Technologies
Product code	DYB
Device class	Class II
Decision date	Mar 15, 1994
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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PROTECTOR INTRODUCER SHEATH

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