510(k) K040495

NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 by Naimco, Inc. — Product Code EGJ

K040495 is an FDA 510(k) premarket notification submitted by Naimco, Inc. for the device "NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405". The FDA issued a decision of Substantially Equivalent on April 22, 2004. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Naimco, Inc. has at least 2 other 510(k) clearances on record.