The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Lumax(modification).
| Device ID | K953734 |
| 510k Number | K953734 |
| Device Name: | LUMAX(MODIFICATION) |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Dennis Madison |
| Correspondent | Dennis Madison MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1996-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937013483 | K953734 | 000 |
| 20888937011160 | K953734 | 000 |
| 20888937011177 | K953734 | 000 |
| 00888937013382 | K953734 | 000 |
| 00888937013405 | K953734 | 000 |
| 00888937013412 | K953734 | 000 |
| 00888937013429 | K953734 | 000 |
| 00888937014044 | K953734 | 000 |
| 50888937013493 | K953734 | 000 |
| 60888937013339 | K953734 | 000 |
| 60888937013360 | K953734 | 000 |
| 60888937013391 | K953734 | 000 |
| 60888937013445 | K953734 | 000 |
| 60888937013452 | K953734 | 000 |
| 60888937013469 | K953734 | 000 |
| 20888937011153 | K953734 | 000 |