The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Iontophoresis Device - Electrode Rh 800.
| Device ID | K896444 |
| 510k Number | K896444 |
| Device Name: | IONTOPHORESIS DEVICE - ELECTRODE RH 800 |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | IOMED, INC. 2471 E. SHADOW WOOD CIRCLE P.O. BOX 17801 Salt Lake City, UT 84117 |
| Contact | Donald F Grabarz |
| Correspondent | Donald F Grabarz IOMED, INC. 2471 E. SHADOW WOOD CIRCLE P.O. BOX 17801 Salt Lake City, UT 84117 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 1989-11-09 |
| Decision Date | 1990-05-10 |