DOUBLE ELUTRA-PACK UNIT

DOUBLE ELUTRA-PACK UNIT is an FDA 510(k)-cleared medical device (K760914) manufactured by Travenol Laboratories, S.A.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 22, 1976. Regulation: 8.