The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Lumax Cystometry Administration Tube Set.
| Device ID | K971911 |
| 510k Number | K971911 |
| Device Name: | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Dennis S Madison |
| Correspondent | Dennis S 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 | 1997-04-28 |
| Decision Date | 1997-06-03 |
| Summary: | summary |