The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Medical Compartment Knee Prosthesis.
| Device ID | K800640 |
| 510k Number | K800640 |
| Device Name: | MEDICAL COMPARTMENT KNEE PROSTHESIS |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | DOW CORNING WRIGHT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-24 |
| Decision Date | 1980-04-21 |