The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Bdh Bipolar Femoral Component A3.
| Device ID | K833404 |
| 510k Number | K833404 |
| Device Name: | BDH BIPOLAR FEMORAL COMPONENT A3 |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | CARBOMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-30 |
| Decision Date | 1984-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024169753 | K833404 | 000 |
| 00889024169838 | K833404 | 000 |
| 00889024169821 | K833404 | 000 |
| 00889024169814 | K833404 | 000 |
| 00889024169807 | K833404 | 000 |
| 00889024169791 | K833404 | 000 |
| 00889024169784 | K833404 | 000 |
| 00889024169777 | K833404 | 000 |
| 00889024169760 | K833404 | 000 |
| 00889024169845 | K833404 | 000 |
| 00889024169852 | K833404 | 000 |
| 00889024169739 | K833404 | 000 |
| 00889024169920 | K833404 | 000 |
| 00889024169913 | K833404 | 000 |
| 00889024169906 | K833404 | 000 |
| 00889024169890 | K833404 | 000 |
| 00889024169883 | K833404 | 000 |
| 00889024169876 | K833404 | 000 |
| 00889024169869 | K833404 | 000 |
| 00889024169746 | K833404 | 000 |