HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR

HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR is an FDA 510(k)-cleared medical device (K905495) manufactured by Frigitronics, 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 April 28, 1991. Regulation: 8.