The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Flexible Cystoscopy Introducing Catheter.
| Device ID | K921120 |
| 510k Number | K921120 |
| Device Name: | FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| 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 | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1992-08-04 |