The following data is part of a premarket notification filed by Seiko Optical Products Of America, Inc. with the FDA for Seiko P-2 & Seiko P-3 (spectacle Lens).
| Device ID | K861684 |
| 510k Number | K861684 |
| Device Name: | SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | SEIKO OPTICAL PRODUCTS OF AMERICA, INC. 575 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Robert Curley |
| Correspondent | Robert Curley SEIKO OPTICAL PRODUCTS OF AMERICA, INC. 575 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-02 |
| Decision Date | 1986-06-09 |