The following data is part of a premarket notification filed by Wr Medical Electronics Co. with the FDA for Iontophoretic Drug Delivery Electrode, Iontophoretic Electrode (active).
| Device ID | K000574 |
| 510k Number | K000574 |
| Device Name: | IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET Stillwater, MN 55082 |
| Contact | Patrick J Anderson |
| Correspondent | Patrick J Anderson WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET Stillwater, MN 55082 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2000-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00702173152929 | K000574 | 000 |
| 00702173151915 | K000574 | 000 |