COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT

COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT is an FDA 510(k)-cleared medical device (K896197) manufactured by Colab Intl., Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 1990. Regulation: 8.