The following data is part of a premarket notification filed by Glenroe Technologies, Inc. with the FDA for Glenroe Chain.
| Device ID | K931462 |
| 510k Number | K931462 |
| Device Name: | GLENROE CHAIN |
| Classification | Band, Elastic, Orthodontic |
| Applicant | GLENROE TECHNOLOGIES, INC. 1912 44TH AVE. E. Bradenton, FL 34203 |
| Contact | John Bozman |
| Correspondent | John Bozman GLENROE TECHNOLOGIES, INC. 1912 44TH AVE. E. 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 | 1993-03-24 |
| Decision Date | 1993-07-22 |