
Customed, Inc.
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URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) is an FDA 510(k)-cleared medical device (K962652) manufactured by Customed, 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 October 3, 1996. Regulation: 8.