SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS

SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS is an FDA 510(k)-cleared medical device (K904223) manufactured by Baxter Healthcare Corp. 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 October 25, 1990. Regulation: 8.