FDA 510(k) Application Details - K250859

Device Classification Name	Ring, Annuloplasty   More FDA Info for this Device
510(K) Number	K250859
Device Name	Ring, Annuloplasty
Applicant	Genesee Biomedical Inc 700 W. Mississippi Ave Unit D-5 Denver, CO 80223 US Other 510(k) Applications for this Company
Contact	James Cross Other 510(k) Applications for this Contact
Regulation Number	870.3800   More FDA Info for this Regulation Number
Classification Product Code	KRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2025
Decision Date	07/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review