BURBANK TENACULUM, MODEL 09-0011-01

BURBANK TENACULUM, MODEL 09-0011-01 is an FDA 510(k)-cleared medical device (K030078) manufactured by Vascular Control Systems, 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 January 23, 2003. Regulation: 8.