SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM is an FDA 510(k)-cleared medical device (K910991) manufactured by Shiley, 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 November 26, 1991. Regulation: 8.