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Integrated Orbital Implants, Inc.
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PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE is an FDA 510(k)-cleared medical device (K000151) manufactured by Integrated Orbital Implants, 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 April 9, 2000. Regulation: 8.