PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067

PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 is an FDA 510(k)-cleared medical device (K003270) 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 December 21, 2000. Regulation: 8.