The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro 32mm Ball.
| Device ID | K872856 |
| 510k Number | K872856 |
| Device Name: | BIOPRO 32MM BALL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Contact | Serafin, Jr.md |
| Correspondent | Serafin, Jr.md BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-21 |
| Decision Date | 1987-08-17 |