GLOBAL HEALTHCARE VAGINAL SPECULUM

GLOBAL HEALTHCARE VAGINAL SPECULUM is an FDA 510(k)-cleared medical device (K013835) manufactured by Dynascend Consulting Int'L, LLC. 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 January 16, 2002. Regulation: 8.