The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic H.p. Trapexial Implant.
| Device ID | K781756 |
| 510k Number | K781756 |
| Device Name: | SILASTIC H.P. TRAPEXIAL IMPLANT |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-16 |
| Decision Date | 1978-11-15 |