The following data is part of a premarket notification filed by Surgitek with the FDA for Lumen-4 Urodynamic Catheter.
| Device ID | K833628 |
| 510k Number | K833628 |
| Device Name: | LUMEN-4 URODYNAMIC CATHETER |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | SURGITEK 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-14 |
| Decision Date | 1983-11-28 |