The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Bipolar Head, Models 18130-18152.
| Device ID | K082705 |
| 510k Number | K082705 |
| Device Name: | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | David Mrak |
| Correspondent | David Mrak BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-16 |
| Decision Date | 2008-12-15 |
| Summary: | summary |