KOLPLAST VAGINAL SPECULUM

KOLPLAST VAGINAL SPECULUM is an FDA 510(k)-cleared medical device (K973853) manufactured by Kolplast Comercial E Industrial Ltda. 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 18, 1997. Regulation: 8.