The following data is part of a premarket notification filed by Naimco, Inc. with the FDA for Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 And 201-405.
| Device ID | K040495 |
| 510k Number | K040495 |
| Device Name: | NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | NAIMCO, INC. 4120 SOUTH CREEK ROAD Chattanooga, TN 37406 |
| Contact | Robert L Mcclure |
| Correspondent | Robert L Mcclure NAIMCO, INC. 4120 SOUTH CREEK ROAD Chattanooga, TN 37406 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-02-26 |
| Decision Date | 2004-04-22 |
| Summary: | summary |