The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Spectacle Frame - Danielle.
| Device ID | K871688 |
| 510k Number | K871688 |
| Device Name: | SPECTACLE FRAME - DANIELLE |
| Classification | Frame, Spectacle |
| Applicant | ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Contact | Darienne Moyer |
| Correspondent | Darienne Moyer ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-29 |
| Decision Date | 1987-05-29 |