The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Dorr Hip Prosthesis, Acetabular Compon.
| Device ID | K842893 |
| 510k Number | K842893 |
| Device Name: | DORR HIP PROSTHESIS, ACETABULAR COMPON |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | CARBOMEDICS, INC. 1300-D EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig CARBOMEDICS, INC. 1300-D EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1984-11-08 |