510(k) K083683

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

K083683 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC". The FDA issued a decision of Substantially Equivalent on February 25, 2009. 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.