POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM

POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM is an FDA 510(k)-cleared medical device (K040817) manufactured by Advanced Urological Developments. 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 June 21, 2004. Regulation: 8.