The following data is part of a premarket notification filed by Empi with the FDA for Dupel Ii Buffered Iontophoresis Electrodes.
| Device ID | K970491 |
| 510k Number | K970491 |
| Device Name: | DUPEL II BUFFERED IONTOPHORESIS ELECTRODES |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
| Contact | Stacy Mattson |
| Correspondent | Stacy Mattson 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 | 1997-02-10 |
| Decision Date | 1997-05-30 |
| Summary: | summary |