510(k) K072655

ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR by Genesee Biomedical, Inc. — Product Code KRH

K072655 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR". The FDA issued a decision of Substantially Equivalent on October 23, 2007. 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.