510(k) K942747

MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) by Engineered Orthopedic Technologies, Inc. — Product Code KDP

K942747 is an FDA 510(k) premarket notification submitted by Engineered Orthopedic Technologies, Inc. for the device "MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )". The FDA issued a decision of Substantially Equivalent on July 21, 1994. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Engineered Orthopedic Technologies, Inc. has at least 1 other 510(k) clearance on record.