The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. Total Hip System.
| Device ID | K944132 |
| 510k Number | K944132 |
| Device Name: | P.F.C. TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. BRUNEL WAY SLOUGH, BERKS England, GB Sl1 Ixr |
| Contact | Patricia Bankert |
| Correspondent | Patricia Bankert JOHNSON & JOHNSON PROFESSIONALS, INC. BRUNEL WAY SLOUGH, BERKS England, GB Sl1 Ixr |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-24 |
| Decision Date | 1995-01-06 |