
Latex Medical Devices, Inc.
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O.N.A.T. is an FDA 510(k)-cleared medical device (K812102) manufactured by Latex Medical Devices, 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 August 30, 1981. Regulation: 8.