The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Urodynamic Catheter.
| Device ID | K915443 |
| 510k Number | K915443 |
| Device Name: | URODYNAMIC CATHETER |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-05 |
| Decision Date | 1992-02-19 |