GENT-L-KARE LACERATION TRAYS

GENT-L-KARE LACERATION TRAYS is an FDA 510(k)-cleared medical device (K950850) manufactured by Premium Plastics, 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 March 13, 1995. Regulation: 8.