The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Whiteside Ortholoc Total Hip Femoral.
| Device ID | K842559 |
| 510k Number | K842559 |
| Device Name: | WHITESIDE ORTHOLOC TOTAL HIP FEMORAL |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS Midland , MI 48640 - |
| Contact | Carmen D Quinsey |
| Correspondent | Carmen D Quinsey 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 | 1984-07-02 |
| Decision Date | 1984-12-20 |