The following data is part of a premarket notification filed by Protek, Inc. with the FDA for P.s.a. Femoral Hip Prosthesis.
| Device ID | K893959 |
| 510k Number | K893959 |
| Device Name: | P.S.A. FEMORAL HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| 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 | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-01 |
| Decision Date | 1989-07-25 |