The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Hydra Vision Urological X-ray System.
| Device ID | K904145 |
| 510k Number | K904145 |
| Device Name: | HYDRA VISION UROLOGICAL X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | Thomas F Donohue |
| Correspondent | Thomas F Donohue MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-07 |
| Decision Date | 1990-12-13 |