The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Biophase Implant Material.
| Device ID | K792329 |
| 510k Number | K792329 |
| Device Name: | BIOPHASE IMPLANT MATERIAL |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-19 |
| Decision Date | 1980-01-23 |