510(k) K973229

D.O.R.C. HEXON ILLUMINATION SYSTEM by Dutch Ophthalmic USA, Inc. — Product Code MPA

K973229 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic USA, Inc. for the device "D.O.R.C. HEXON ILLUMINATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 25, 1997. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Dutch Ophthalmic USA, Inc. has at least 9 other 510(k) clearances on record.