BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM

BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM is an FDA 510(k)-cleared medical device (K091958) manufactured by Glenveigh Surgical, LLC. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2010. Regulation: 8.