510(k) K942005

GIP/MED-GLOBE STONE EXTRACTOR BASKETS by Medi-Globe Corp. — Product Code LQR

K942005 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "GIP/MED-GLOBE STONE EXTRACTOR BASKETS". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Medi-Globe Corp. has at least 10 other 510(k) clearances on record.