The following data is part of a premarket notification filed by Epson El Paso, Inc. with the FDA for Seiko Plax Diacoat Ii & Seiko Plax S.v.p..
| Device ID | K875063 |
| 510k Number | K875063 |
| Device Name: | SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | EPSON EL PASO, INC. 2000 MBANK PLAZA P.O. DRAWER 2800 El Paso, TX 79901 |
| Contact | Scanlon, Jr |
| Correspondent | Scanlon, Jr EPSON EL PASO, INC. 2000 MBANK PLAZA P.O. DRAWER 2800 El Paso, TX 79901 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-09 |
| Decision Date | 1988-02-22 |