PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER

PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER is an FDA 510(k)-cleared medical device (K943836) manufactured by Orion Life Systems, 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 November 20, 1994. Regulation: 8.