The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Hemi Wrist Implant H.p. (rad.).
| Device ID | K812053 |
| 510k Number | K812053 |
| Device Name: | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) |
| Classification | Prosthesis, Wrist, Hemi-, Ulnar |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KXE |
| CFR Regulation Number | 888.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-21 |
| Decision Date | 1981-08-18 |