
Scott E Allen CP
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PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS is an FDA 510(k)-cleared medical device (K012804) manufactured by Scott E Allen CP. 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 16, 2002. Regulation: 8.