The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Psl Total Hip Replacement System.
| Device ID | K922500 |
| 510k Number | K922500 |
| Device Name: | PSL TOTAL HIP REPLACEMENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Contact | Al Lippincott |
| Correspondent | Al Lippincott BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-27 |
| Decision Date | 1994-01-07 |