The following data is part of a premarket notification filed by Vyteris, Inc. with the FDA for Northstar Lidocaine Iontophoretic Controller (northstar Controller-d).
| Device ID | K031551 |
| 510k Number | K031551 |
| Device Name: | NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) |
| Classification | Device, Iontophoresis, Specific Uses |
| Applicant | VYTERIS, INC. 13-01 POLLITT DRIVE Fair Lawn, NJ 07410 |
| Contact | George M Baskinger |
| Correspondent | George M Baskinger VYTERIS, INC. 13-01 POLLITT DRIVE Fair Lawn, NJ 07410 |
| Product Code | KTB |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-05-19 |
| Decision Date | 2003-08-20 |
| Summary: | summary |