The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Champion Iontophoretic Drug Delivery Device.
| Device ID | K063465 |
| 510k Number | K063465 |
| Device Name: | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | IOMED, INC. 2441 SOUTH 3850 WEST, SUITE A Salt Lake City, UT 84120 -9941 |
| Contact | Curtis Jenson |
| Correspondent | Curtis Jenson IOMED, INC. 2441 SOUTH 3850 WEST, SUITE A Salt Lake City, UT 84120 -9941 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-16 |
| Decision Date | 2007-02-28 |
| Summary: | summary |