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Rehabilitation Institute,Loma Linda University Med
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LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET is an FDA 510(k)-cleared medical device (K023572) manufactured by Rehabilitation Institute,Loma Linda University Med. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2003. Regulation: 8.