The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Lumax (modification).
| Device ID | K954093 |
| 510k Number | K954093 |
| Device Name: | LUMAX (MODIFICATION) |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Brad Slaker |
| Correspondent | Brad Slaker 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 | 1995-08-09 |
| Decision Date | 1996-01-11 |