LERMAN & SON CRANIAL ORTHOSIS HELMET

LERMAN & SON CRANIAL ORTHOSIS HELMET is an FDA 510(k)-cleared medical device (K012830) manufactured by Lerman & Son. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2001. Regulation: 8.