
Carl Zeiss, Inc.
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OPMI TWINER SURGICAL MICROSCOPE is an FDA 510(k)-cleared medical device (K983868) manufactured by Carl Zeiss, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 28, 1999. Regulation: 8.