CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)

CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) is an FDA 510(k)-cleared medical device (K070694) manufactured by Mike Miner. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 9, 2007. Regulation: 8.