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 |