The following data is part of a premarket notification filed by Seiko Corp. with the FDA for Spectacle Frame.
Device ID | K900732 |
510k Number | K900732 |
Device Name: | SPECTACLE FRAME |
Classification | Frame, Spectacle |
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 | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-16 |
Decision Date | 1990-06-20 |