The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Richards Acetabular Brush.
| Device ID | K813093 |
| 510k Number | K813093 |
| Device Name: | RICHARDS ACETABULAR BRUSH |
| Classification | Rasp |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HTR |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-02 |
| Decision Date | 1981-11-20 |