EXTENSION SET, MODELS 1911-512

EXTENSION SET, MODELS 1911-512 is an FDA 510(k)-cleared medical device (K020926) manufactured by Epimed International, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 2002. Regulation: 8.