ASCENSION SILLICONE MCP

ASCENSION SILLICONE MCP is an FDA 510(k)-cleared medical device (K022892) manufactured by Ascension Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 24, 2002. Regulation: 8.