`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH

`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH is an FDA 510(k)-cleared medical device (K984446) manufactured by Urocor, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 1999. Regulation: 8.