510(k) K910828

LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS by Ocular Instruments, Inc. — Product Code MLP

K910828 is an FDA 510(k) premarket notification submitted by Ocular Instruments, Inc. for the device "LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS". The FDA issued a decision of Substantially Equivalent on August 21, 1991. The device falls under product code MLP (Keratoprosthesis, Temporary Implant, Surgical Use), a Class II device regulated under 21 CFR 886.3400. Ocular Instruments, Inc. has at least 10 other 510(k) clearances on record.