510(k) K093903

ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC by Genesee Biomedical, Inc. — Product Code KRH

K093903 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC". The FDA issued a decision of Substantially Equivalent on July 15, 2010. 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.