K-number	K992056
Device name	ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
Applicant	Sulzer Carbomedics, Inc.
Product code	KRH
Device class	Class II
Decision date	Oct 12, 1999
Decision	Substantially Equivalent
Regulation	870.3800

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ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800

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