The following data is part of a premarket notification filed by Icat Systems with the FDA for Uniquet.
| Device ID | K931198 |
| 510k Number | K931198 |
| Device Name: | UNIQUET |
| Classification | Tourniquet, Nonpneumatic |
| Applicant | ICAT SYSTEMS 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary Allsebrook |
| Correspondent | Gary Allsebrook ICAT SYSTEMS 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Product Code | GAX |
| CFR Regulation Number | 878.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1993-09-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UNIQUET 74209169 1865230 Dead/Cancelled |
INGRESS TECHNOLOGIES, INC. 1991-10-03 |