The following data is part of a premarket notification filed by Gauthier Biomedical, Inc. with the FDA for Intellitorq.
Device ID | K180092 |
510k Number | K180092 |
Device Name: | Intellitorq |
Classification | Wrench |
Applicant | Gauthier Biomedical, Inc. 2221 Washington St. Grafton, WI 53024 |
Contact | Austin Braganza |
Correspondent | Austin Braganza Gauthier Biomedical, Inc. 2221 Washington St. Grafton, WI 53024 |
Product Code | HXC |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-01-12 |
Decision Date | 2018-03-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTELLITORQ 85843876 4614501 Live/Registered |
Gauthier Biomedical, Inc. 2013-02-07 |