CURELLE, PREFERRED CURELLE, CUTEQ 2.5

CURELLE, PREFERRED CURELLE, CUTEQ 2.5 is an FDA 510(k)-cleared medical device (K020628) manufactured by Bioteque America, 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 May 23, 2002. Regulation: 8.