K-number	K061369
Device name	TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
Applicant	Cardiacassist, Inc.
Product code	DWA
Device class	Class II
Decision date	Aug 22, 2006
Decision	Substantially Equivalent
Regulation	870.4380

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View the full FDA submission: accessdata.fda.gov

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TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500

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