SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 is an FDA 510(k)-cleared medical device (K000420) manufactured by Retinalabs.Com. 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 May 7, 2000. Regulation: 8.