The following data is part of a premarket notification filed by Aoyama Optical Co., Ltd. with the FDA for Frame, Spectacle.
Device ID | K933436 |
510k Number | K933436 |
Device Name: | FRAME, SPECTACLE |
Classification | Frame, Spectacle |
Applicant | AOYAMA OPTICAL CO., LTD. 2-3-30, KAMINAKA-CHO Sabae-city, Fukui-pref., JP 916-8505 |
Contact | A Anakura |
Correspondent | A Anakura AOYAMA OPTICAL CO., LTD. 2-3-30, KAMINAKA-CHO Sabae-city, Fukui-pref., JP 916-8505 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-13 |
Decision Date | 1993-09-09 |