The following data is part of a premarket notification filed by J.e. Hanger & Co. Ltd. with the FDA for Drushoe.
| Device ID | K790326 |
| 510k Number | K790326 |
| Device Name: | DRUSHOE |
| Classification | Orthosis, Corrective Shoe |
| Applicant | J.E. HANGER & CO. LTD. 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 | 1979-02-15 |
| Decision Date | 1979-02-26 |