510(k) K001964

OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION by Lobob Laboratories, Inc. — Product Code MRC

K001964 is an FDA 510(k) premarket notification submitted by Lobob Laboratories, Inc. for the device "OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION". The FDA issued a decision of Substantially Equivalent on July 18, 2000. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Lobob Laboratories, Inc. has at least 3 other 510(k) clearances on record.