The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Hydrajust Iv Urological Table.
| Device ID | K920742 |
| 510k Number | K920742 |
| Device Name: | HYDRAJUST IV UROLOGICAL TABLE |
| Classification | Table, Radiographic, Tilting |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | Mark L Freidman |
| Correspondent | Mark L Freidman MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-19 |
| Decision Date | 1992-04-27 |