The following data is part of a premarket notification filed by Empi with the FDA for Dupel Iontophoresis System.
| Device ID | K991991 |
| 510k Number | K991991 |
| Device Name: | DUPEL IONTOPHORESIS SYSTEM |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
| Contact | Kristy K Mollner |
| Correspondent | Kristy K Mollner EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-14 |
| Decision Date | 1999-09-10 |
| Summary: | summary |