The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Bdh Unipolar Femoral Component A2.
| Device ID | K833403 |
| 510k Number | K833403 |
| Device Name: | BDH UNIPOLAR FEMORAL COMPONENT A2 |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | CARBOMEDICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-30 |
| Decision Date | 1984-01-10 |