The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Slr Bipolar Hip Endoprosthesis.
| Device ID | K861566 |
| 510k Number | K861566 |
| Device Name: | SLR BIPOLAR HIP ENDOPROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Spires, Jr |
| Correspondent | Spires, Jr DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-25 |
| Decision Date | 1986-05-12 |