K-number	K090428
Device name	ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
Applicant	Genesee Biomedical, Inc.
Product code	KRH
Device class	Class II
Decision date	May 7, 2009
Decision	Substantially Equivalent
Regulation	870.3800

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View the full FDA submission: accessdata.fda.gov

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ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC

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