The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Taleisnik Total Wrist Prosthesis.
| Device ID | K800602 |
| 510k Number | K800602 |
| Device Name: | TALEISNIK TOTAL WRIST PROSTHESIS |
| Classification | Prosthesis, Wrist, Semi-constrained |
| Applicant | DOW CORNING WRIGHT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWM |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-17 |
| Decision Date | 1980-08-27 |