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The Ludlow Company LP
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LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES is an FDA 510(k)-cleared medical device (K012218) manufactured by The Ludlow Company LP. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 11, 2001. Regulation: 8.