The following data is part of a premarket notification filed by Seiko Corp. with the FDA for Seiko P-6 Progressive Spectacle Lenses.
Device ID | K884360 |
510k Number | K884360 |
Device Name: | SEIKO P-6 PROGRESSIVE SPECTACLE LENSES |
Classification | Lens, Spectacle, Non-custom (prescription) |
Applicant | SEIKO CORP. 575 CORPORATE DR. Mahwah, NJ 07430 |
Contact | Robert L Curley |
Correspondent | Robert L Curley SEIKO CORP. 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 | 1988-10-17 |
Decision Date | 1988-11-15 |