FILTER FLOW MASK CAT. #350

FILTER FLOW MASK CAT. #350 is an FDA 510(k)-cleared medical device (K812997) manufactured by Eldredge Mfg. Co.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 1981. Regulation: 8.