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Abbott Medical Optics, Inc.
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LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) is an FDA 510(k)-cleared medical device (K121721) manufactured by Abbott Medical Optics, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 2012. Regulation: 8.