KEGELMASTER 2000

KEGELMASTER 2000 is an FDA 510(k)-cleared medical device (K023305) manufactured by Kegelmaster 2000 , Ltd.. 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 25, 2002. Regulation: 8.