The following data is part of a premarket notification filed by Glenroe Technologies with the FDA for Glenroe Ortho Seps.
| Device ID | K924139 |
| 510k Number | K924139 |
| Device Name: | GLENROE ORTHO SEPS |
| 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 | 1993-04-08 |