K-number	K912443
Device name	CANDELA INTRODUCER SHEATH SYSTEM
Applicant	Candela Laser Corp.
Product code	FDE
Device class	Class II
Decision date	Aug 16, 1991
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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CANDELA INTRODUCER SHEATH SYSTEM

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