The following data is part of a premarket notification filed by Alimed, Inc. with the FDA for Plastazote Shoe.
| Device ID | K801743 |
| 510k Number | K801743 |
| Device Name: | PLASTAZOTE SHOE |
| Classification | Orthosis, Corrective Shoe |
| Applicant | ALIMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNP |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-08-07 |