
Cranial Technologies, Inc.
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DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND is an FDA 510(k)-cleared medical device (DEN980001) manufactured by Cranial Technologies, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 1998. Regulation: 8.