
Karl Storz Endoscopy
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KSEA UNIMAT 45 is an FDA 510(k)-cleared medical device (K981703) manufactured by Karl Storz Endoscopy. 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 August 11, 1998. Regulation: 8.