AME(R) UNIVERSIAL CABLE SYSTEM

AME(R) UNIVERSIAL CABLE SYSTEM is an FDA 510(k)-cleared medical device (K932687) manufactured by American Medical Electronics, 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 May 2, 1994. Regulation: 8.