BECKER BAND CRANIAL REMOLDING ORTHOSIS

BECKER BAND CRANIAL REMOLDING ORTHOSIS is an FDA 510(k)-cleared medical device (K013719) manufactured by Becker Orthopedic Appliance Co.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 2002. Regulation: 8.