The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Tf-ii Hip Prosthesis.
| Device ID | K843995 |
| 510k Number | K843995 |
| Device Name: | TF-II HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS Midland, MI 48640 |
| Contact | Harvey L Steinberg |
| Correspondent | Harvey L Steinberg DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS Midland, MI 48640 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1985-04-23 |