MODIFICATION TO: SAVI APPLICATOR KIT

MODIFICATION TO: SAVI APPLICATOR KIT is an FDA 510(k)-cleared medical device (K080565) manufactured by Cianna Medical, 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 3, 2008. Regulation: 8.