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Integra LifeSciences Corporation
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INTEGRA LED SURGICAL HEADLIGHT SYSTEM is an FDA 510(k)-cleared medical device (K110528) manufactured by Integra LifeSciences Corporation. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 10, 2011. Regulation: 8.