PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)

PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) is an FDA 510(k)-cleared medical device (K954331) manufactured by Pall Biomedical Products Co.. 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 January 8, 1997. Regulation: 8.