KUSKE BREAST APPLICATOR SET, MODEL 189.006

KUSKE BREAST APPLICATOR SET, MODEL 189.006 is an FDA 510(k)-cleared medical device (K022635) 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 September 5, 2002. Regulation: 8.