PLEUROFIX THORACENTESIS KIT

PLEUROFIX THORACENTESIS KIT is an FDA 510(k)-cleared medical device (K820004) manufactured by Burron Medical Products, Inc.. 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 February 3, 1982. Regulation: 8.