EDWARDS-WALLACE BOURNE HALL CATHETER

EDWARDS-WALLACE BOURNE HALL CATHETER is an FDA 510(k)-cleared medical device (K910577) manufactured by Marlo Surgical Technology. 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 May 8, 1991. Regulation: 8.