The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Hugh Young Ii Urological Table.
| Device ID | K891403 |
| 510k Number | K891403 |
| Device Name: | HUGH YOUNG II UROLOGICAL TABLE |
| Classification | Table, Radiographic, Non-tilting, Powered |
| 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 | IZZ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-14 |
| Decision Date | 1989-06-22 |