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 |