OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM

OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM is an FDA 510(k)-cleared medical device (K091937) manufactured by Obp Corporation. 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 September 8, 2009. Regulation: 8.