The following data is part of a premarket notification filed by Biomedics with the FDA for Kampner Hinged Toe Prosthesis.
| Device ID | K801345 |
| 510k Number | K801345 |
| Device Name: | KAMPNER HINGED TOE PROSTHESIS |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | BIOMEDICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-06 |
| Decision Date | 1980-07-08 |