510(k) K051993

LMA FASTRACH ETT SINGLE USE by The Laryngeal Mask Co., Ltd. — Product Code BTR

K051993 is an FDA 510(k) premarket notification submitted by The Laryngeal Mask Co., Ltd. for the device "LMA FASTRACH ETT SINGLE USE". The FDA issued a decision of Substantially Equivalent on December 13, 2005. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. The Laryngeal Mask Co., Ltd. has at least 3 other 510(k) clearances on record.