The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Ultima*unipolar Head And Adapter Sleeves.
| Device ID | K965156 |
| 510k Number | K965156 |
| Device Name: | ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Sally Maher |
| Correspondent | Sally Maher JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-01-24 |
| Summary: | summary |