TEMP. REPAIR KIT-DUAL LUMEN CATHETER

TEMP. REPAIR KIT-DUAL LUMEN CATHETER is an FDA 510(k)-cleared medical device (K831587) manufactured by Norton Performance Plastics Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 1983. Regulation: 8.