KENTEX DISPOSABLE VAGINAL SPECULUM

KENTEX DISPOSABLE VAGINAL SPECULUM is an FDA 510(k)-cleared medical device (K030693) manufactured by Kentron Health Care, 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 August 26, 2003. Regulation: 8.