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Penumbra, Inc.
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PENUMBRA EMBOLIZATION COIL SYSTEM is an FDA 510(k)-cleared medical device (K103305) manufactured by Penumbra, 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 January 25, 2011. Regulation: 8.