510(k) K942544

GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS by Medi-Globe Corp. — Product Code LQC

K942544 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500. Medi-Globe Corp. has at least 10 other 510(k) clearances on record.