510(k) K202253

TruForm Sievers Annuloplasty Ring by Genesee Biomedical, Inc. — Product Code KRH

K202253 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "TruForm Sievers Annuloplasty Ring". The FDA issued a decision of Substantially Equivalent on October 6, 2020. 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.