INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER

INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER is an FDA 510(k)-cleared medical device (K970492) 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 April 8, 1997. Regulation: 8.