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KARL STORZ Endoscopy-America, Inc.
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KSEA MINIATURE TELESCOPE AND ACCESSORIES is an FDA 510(k)-cleared medical device (K010987) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 18, 2001. Regulation: 8.