The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Townley Cox Comb Acetabular Component.
| Device ID | K882869 |
| 510k Number | K882869 |
| Device Name: | TOWNLEY COX COMB ACETABULAR COMPONENT |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-11 |
| Decision Date | 1988-10-14 |