The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Hemi-endo Modular Head For Psl System.
| Device ID | K895886 |
| 510k Number | K895886 |
| Device Name: | BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-05 |
| Decision Date | 1989-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M209101960 | K895886 | 000 |
| M209101800 | K895886 | 000 |
| M209101810 | K895886 | 000 |
| M209101820 | K895886 | 000 |
| M209101830 | K895886 | 000 |
| M209101840 | K895886 | 000 |
| M209101850 | K895886 | 000 |
| M209101860 | K895886 | 000 |
| M209101870 | K895886 | 000 |
| M209101880 | K895886 | 000 |
| M209101890 | K895886 | 000 |
| M209101900 | K895886 | 000 |
| M209101910 | K895886 | 000 |
| M209101920 | K895886 | 000 |
| M209101930 | K895886 | 000 |
| M209101940 | K895886 | 000 |
| M209101950 | K895886 | 000 |
| M209101790 | K895886 | 000 |