
Neotech Products, Inc.
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URO-TOTE LEG BAG is an FDA 510(k)-cleared medical device (K921024) manufactured by Neotech Products, 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 September 1, 1992. Regulation: 8.