510(k) K922880

XOMED TREACE JET VENTILATION TUBE by Xomed-Treace, Inc. — Product Code BTR

K922880 is an FDA 510(k) premarket notification submitted by Xomed-Treace, Inc. for the device "XOMED TREACE JET VENTILATION TUBE". The FDA issued a decision of Substantially Equivalent on April 15, 1993. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Xomed-Treace, Inc. has at least 10 other 510(k) clearances on record.