PROSTEC 125I BRACHYTHERAPY SEEDS

PROSTEC 125I BRACHYTHERAPY SEEDS is an FDA 510(k)-cleared medical device (K993280) manufactured by Prostec, LLC. 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 13, 2000. Regulation: 8.