The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Femoral Hip Component.
Device ID | K872535 |
510k Number | K872535 |
Device Name: | BIOPRO FEMORAL HIP COMPONENT |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant | BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
Contact | Serafin, Jr. |
Correspondent | Serafin, Jr. 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 | 1987-06-26 |
Decision Date | 1987-08-26 |