
Cardinalhealth
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Salem Sump Dual Lumen Stomach Tube with ENFit Connection is an FDA 510(k)-cleared medical device (K190923) manufactured by Cardinalhealth. 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 November 6, 2019. Regulation: 8.