ACKRAD HYSTEROSALPINGOGRAPHY SET

ACKRAD HYSTEROSALPINGOGRAPHY SET is an FDA 510(k)-cleared medical device (K842231) manufactured by Ackrad Laboratories. 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 September 18, 1984. Regulation: 8.