TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT

TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT is an FDA 510(k)-cleared medical device (K110971) manufactured by Navotek Medical, Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2012. Regulation: 8.