ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF

ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF is an FDA 510(k)-cleared medical device (K052565) manufactured by Genesee Biomedical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 2005. Regulation: 8.