The following data is part of a premarket notification filed by Sorensen Research with the FDA for Iontophoresis System Module, Dm 500.
| Device ID | K770717 |
| 510k Number | K770717 |
| Device Name: | IONTOPHORESIS SYSTEM MODULE, DM 500 |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | SORENSEN RESEARCH 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-04-18 |
| Decision Date | 1977-08-15 |