510(k) K052565

ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF by Genesee Biomedical, Inc. — Product Code KRH

K052565 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF". The FDA issued a decision of Substantially Equivalent on November 17, 2005. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Genesee Biomedical, Inc. has at least 10 other 510(k) clearances on record.