The following data is part of a premarket notification filed by Glenroe Technologies with the FDA for Tuff Ties.
| Device ID | K924140 |
| 510k Number | K924140 |
| Device Name: | TUFF TIES |
| Classification | Band, Elastic, Orthodontic |
| Applicant | GLENROE TECHNOLOGIES 1912 44TH AVE., EAST Bradenton, FL 34203 |
| Contact | John F Bozman |
| Correspondent | John F Bozman GLENROE TECHNOLOGIES 1912 44TH AVE., EAST Bradenton, FL 34203 |
| Product Code | ECI |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-18 |
| Decision Date | 1993-04-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TUFF TIES 76388732 not registered Dead/Abandoned |
Flaming River Industries, Inc. 2002-03-29 |
![]() TUFF TIES 73815664 1640529 Dead/Expired |
IMARC, INC. 1989-07-28 |