The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Uni-polar Head.
| Device ID | K896580 |
| 510k Number | K896580 |
| Device Name: | UNI-POLAR HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LZY |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-17 |
| Decision Date | 1990-02-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010196583 | K896580 | 000 |
| 03596010079770 | K896580 | 000 |
| 03596010079763 | K896580 | 000 |
| 03596010079756 | K896580 | 000 |
| 03596010079749 | K896580 | 000 |
| 03596010079732 | K896580 | 000 |
| 03596010079725 | K896580 | 000 |
| 03596010079718 | K896580 | 000 |
| 03596010079701 | K896580 | 000 |
| 03596010079695 | K896580 | 000 |
| 03596010079688 | K896580 | 000 |
| 03596010079671 | K896580 | 000 |
| 03596010079664 | K896580 | 000 |
| 03596010079787 | K896580 | 000 |
| 03596010079794 | K896580 | 000 |
| 03596010196576 | K896580 | 000 |
| 03596010196569 | K896580 | 000 |
| 03596010196552 | K896580 | 000 |
| 03596010196545 | K896580 | 000 |
| 03596010079879 | K896580 | 000 |
| 03596010079862 | K896580 | 000 |
| 03596010079855 | K896580 | 000 |
| 03596010079848 | K896580 | 000 |
| 03596010079831 | K896580 | 000 |
| 03596010079824 | K896580 | 000 |
| 03596010079817 | K896580 | 000 |
| 03596010079800 | K896580 | 000 |
| 03596010079633 | K896580 | 000 |