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Leonhard Lang GmbH
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SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL is an FDA 510(k)-cleared medical device (K081371) manufactured by Leonhard Lang GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 23, 2008. Regulation: 8.