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 |