
Nucletron Corp.
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INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 is an FDA 510(k)-cleared medical device (K041715) manufactured by Nucletron Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 2005. Regulation: 8.