The following data is part of a premarket notification filed by Hamilton Kent with the FDA for Sorbothane.
| Device ID | K810228 |
| 510k Number | K810228 |
| Device Name: | SORBOTHANE |
| Classification | Orthosis, Corrective Shoe |
| Applicant | HAMILTON KENT 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 | 1981-01-27 |
| Decision Date | 1981-02-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SORBOTHANE 73393534 1313137 Live/Registered |
Sorbo, Inc. 1982-09-29 |
![]() SORBOTHANE 73277649 1208333 Dead/Cancelled |
Hamilton Kent Manufacturing Company 1980-09-12 |