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Ocular Instruments, Inc.
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DISPOSABLE VITRECTOMY LENS is an FDA 510(k)-cleared medical device (K012096) manufactured by Ocular Instruments, 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 August 23, 2001. Regulation: 8.