`INEAR WRIST COIL, MODEL 440GE-09

`INEAR WRIST COIL, MODEL 440GE-09 is an FDA 510(k)-cleared medical device (K991113) manufactured by Medical Advances, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 1999. Regulation: 8.