SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE

SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE is an FDA 510(k)-cleared medical device (K901078) manufactured by L H M Ent., Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 17, 1990. Regulation: 8.