510(k) K912753

XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL by Xomed-Treace, Inc. — Product Code GCX

K912753 is an FDA 510(k) premarket notification submitted by Xomed-Treace, Inc. for the device "XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Xomed-Treace, Inc. has at least 10 other 510(k) clearances on record.