ECHO GEL (RAINFOREST)

ECHO GEL (RAINFOREST) is an FDA 510(k)-cleared medical device (K895100) manufactured by Lead-Lok, 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 November 2, 1989. Regulation: 8.