HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM

HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM is an FDA 510(k)-cleared medical device (K970078) manufactured by Davol Inc., Sub. C. R. Bard, Inc.. 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 December 10, 1997. Regulation: 8.