The following data is part of a premarket notification filed by Eureka Optics, Inc. with the FDA for Frame, Spectacle.
| Device ID | K903949 |
| 510k Number | K903949 |
| Device Name: | FRAME, SPECTACLE |
| Classification | Frame, Spectacle |
| Applicant | EUREKA OPTICS, INC. P.O. BOX 332 Toegu, Korea, KR |
| Contact | C. B Sohn |
| Correspondent | C. B Sohn EUREKA OPTICS, INC. P.O. BOX 332 Toegu, Korea, KR |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1990-09-10 |