510(k) K062475

LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM by The Laryngeal Mask Co., Ltd. — Product Code FFK

K062475 is an FDA 510(k) premarket notification submitted by The Laryngeal Mask Co., Ltd. for the device "LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM". The FDA issued a decision of Substantially Equivalent on May 9, 2007. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. The Laryngeal Mask Co., Ltd. has at least 3 other 510(k) clearances on record.