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Nucletron Corporation
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NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 is an FDA 510(k)-cleared medical device (K032372) manufactured by Nucletron Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 14, 2003. Regulation: 8.