EDSLAB CLOSED INJECTATE DELIVERY SYSTEM

EDSLAB CLOSED INJECTATE DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K811399) manufactured by American Edwards Laboratories. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 1981. Regulation: 8.