K-number	K112032
Device name	8FR TURBO - TANDEM SYSTEM
Applicant	Spectranetics Corp.
Product code	DQY
Device class	Class II
Decision date	Oct 17, 2011
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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8FR TURBO - TANDEM SYSTEM

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