MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )

MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) is an FDA 510(k)-cleared medical device (K942747) manufactured by Engineered Orthopedic Technologies, 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 July 20, 1994. Regulation: 8.