510(k) K011456

DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES by Sauflon Pharmaceuticals, Ltd. — Product Code MRC

K011456 is an FDA 510(k) premarket notification submitted by Sauflon Pharmaceuticals, Ltd. for the device "DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on July 17, 2001. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Sauflon Pharmaceuticals, Ltd. has at least 10 other 510(k) clearances on record.