510(k) K902491

ECKHARDT TEMPORARY KERATOPROSTHESIS by Dutch Ophthalmic USA, Inc. — Product Code MLP

K902491 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic USA, Inc. for the device "ECKHARDT TEMPORARY KERATOPROSTHESIS". The FDA issued a decision of Substantially Equivalent on June 26, 1990. The device falls under product code MLP (Keratoprosthesis, Temporary Implant, Surgical Use), a Class II device regulated under 21 CFR 886.3400. Dutch Ophthalmic USA, Inc. has at least 9 other 510(k) clearances on record.