ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM

ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM is an FDA 510(k)-cleared medical device (K912019) manufactured by Gish Biomedical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 1991. Regulation: 8.