The following data is part of a premarket notification filed by Glenroe with the FDA for Glenroe Glow In Dark Elastomeric Ligatures.
| Device ID | K973495 |
| 510k Number | K973495 |
| Device Name: | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES |
| Classification | Band, Elastic, Orthodontic |
| Applicant | GLENROE 1912 44TH AVENUE E. Bradenton, FL 34203 |
| Contact | John Bozman |
| Correspondent | John Bozman GLENROE 1912 44TH AVENUE 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 | 1997-09-16 |
| Decision Date | 1997-12-01 |