AMER. EDWARDS LAB FLEXISCOPE OBTURATOR

AMER. EDWARDS LAB FLEXISCOPE OBTURATOR is an FDA 510(k)-cleared medical device (K842323) manufactured by American Edwards Laboratories. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 1984. Regulation: 8.