ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001

ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 is an FDA 510(k)-cleared medical device (K020592) manufactured by Alba-Waldensian, 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 April 2, 2002. Regulation: 8.