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KARL STORZ Endoscopy-America, Inc.
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KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C is an FDA 510(k)-cleared medical device (K091968) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2009. Regulation: 8.

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