The following data is part of a premarket notification filed by Seiko Optical Products Of America, Inc. with the FDA for Seiko Eyeglass Frame.
| Device ID | K942513 |
| 510k Number | K942513 |
| Device Name: | SEIKO EYEGLASS FRAME |
| Classification | Frame, Spectacle |
| Applicant | SEIKO OPTICAL PRODUCTS OF AMERICA, INC. 575 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Daniel Mathis |
| Correspondent | Daniel Mathis SEIKO OPTICAL PRODUCTS OF AMERICA, INC. 575 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-26 |
| Decision Date | 1994-07-15 |