The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Medion 6000.
| Device ID | K020476 |
| 510k Number | K020476 |
| Device Name: | MEDION 6000 |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | SELECTIVE MED COMPONENTS, INC. 6 MECHANIC ST. Mount Vernon, OH 43050 |
| Contact | Richard Fisher |
| Correspondent | Richard Fisher SELECTIVE MED COMPONENTS, INC. 6 MECHANIC ST. Mount Vernon, OH 43050 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-12 |
| Decision Date | 2002-05-03 |
| Summary: | summary |