The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Prosthesis, Total Hip-rasp.
| Device ID | K760109 |
| 510k Number | K760109 |
| Device Name: | PROSTHESIS, TOTAL HIP-RASP |
| Classification | Rasp |
| Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTR |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-24 |
| Decision Date | 1976-07-20 |