510(k) K052055

SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 by Smisson-Cartledge Biomedical, LLC — Product Code LGZ

K052055 is an FDA 510(k) premarket notification submitted by Smisson-Cartledge Biomedical, LLC for the device "SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200". The FDA issued a decision of Substantially Equivalent on October 26, 2006. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Smisson-Cartledge Biomedical, LLC has at least 1 other 510(k) clearance on record.