K-number	K013972
Device name	H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
Applicant	Ackard Laboratories
Product code	LKF
Device class	Class II
Decision date	Dec 17, 2001
Decision	Substantially Equivalent
Regulation	884.4530

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H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005

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