ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION

ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION is an FDA 510(k)-cleared medical device (K935617) manufactured by Davol Inc., Sub. C. R. Bard, 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 September 15, 1994. Regulation: 8.