The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c.(r) Bipolar Hip System - 22mm Bipolar.
| Device ID | K945793 |
| 510k Number | K945793 |
| Device Name: | P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Contact | J T Dorriety |
| Correspondent | J T Dorriety JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-25 |
| Decision Date | 1995-04-10 |