The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Hydrajust Iii Urological Table.
| Device ID | K860040 |
| 510k Number | K860040 |
| Device Name: | HYDRAJUST III UROLOGICAL TABLE |
| Classification | Table, Cystometric, Non-electric And Accessories |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | James S Adams |
| Correspondent | James S Adams MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | KQS |
| CFR Regulation Number | 876.4890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-02-10 |