
Kendall Healthcare Products Co. Div.Of Tyco Health
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NEEDLELESS URINE SAMPLING PORT is an FDA 510(k)-cleared medical device (K944236) manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. 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 15, 1994. Regulation: 8.