The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. Apical Plug.
| Device ID | K944769 |
| 510k Number | K944769 |
| Device Name: | P.F.C. APICAL PLUG |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Contact | J. Teresa Dorriety |
| Correspondent | J. Teresa Dorriety JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1994-12-08 |