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Leica Microsystems (Schweiz) AG
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LEICA FL800 is an FDA 510(k)-cleared medical device (K080612) manufactured by Leica Microsystems (Schweiz) AG. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 8, 2008. Regulation: 8.