510(k) K082520

SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES by Mallinckrodt Medical — Product Code BTR

K082520 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES". The FDA issued a decision of Substantially Equivalent on October 2, 2008. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Mallinckrodt Medical has at least 10 other 510(k) clearances on record.