The following data is part of a premarket notification filed by Protek, Inc. with the FDA for C.l.e. Acetabular Cup.
| Device ID | K870922 |
| 510k Number | K870922 |
| Device Name: | C.L.E. ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
| Contact | Kenneth Epling |
| Correspondent | Kenneth Epling PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-10-28 |