STERILE ISOTONIC SALINE & STERILE WATER

STERILE ISOTONIC SALINE & STERILE WATER is an FDA 510(k)-cleared medical device (K954442) manufactured by Medcare Custom Packaging, 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 December 20, 1995. Regulation: 8.