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 |