The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Illuminated Ureteral Catheter.
| Device ID | K923436 |
| 510k Number | K923436 |
| Device Name: | ILLUMINATED URETERAL CATHETER |
| Classification | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Tammy Bacon |
| Correspondent | Tammy Bacon COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | FCS |
| CFR Regulation Number | 876.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-13 |
| Decision Date | 1993-03-05 |