
Dutch Ophthalmic USA, Inc.
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D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM is an FDA 510(k)-cleared medical device (K010082) manufactured by Dutch Ophthalmic USA, 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 March 11, 2001. Regulation: 8.