510(k) K983484

DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE by Empi — Product Code EGJ

K983484 is an FDA 510(k) premarket notification submitted by Empi for the device "DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 28, 1998. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Empi has at least 10 other 510(k) clearances on record.