FRAME, SPECTACLE

Frame, Spectacle

AOYAMA OPTICAL CO., LTD.

The following data is part of a premarket notification filed by Aoyama Optical Co., Ltd. with the FDA for Frame, Spectacle.

Pre-market Notification Details

Device IDK933436
510k NumberK933436
Device Name:FRAME, SPECTACLE
ClassificationFrame, Spectacle
Applicant AOYAMA OPTICAL CO., LTD. 2-3-30, KAMINAKA-CHO Sabae-city, Fukui-pref.,  JP 916-8505
ContactA Anakura
CorrespondentA Anakura
AOYAMA OPTICAL CO., LTD. 2-3-30, KAMINAKA-CHO Sabae-city, Fukui-pref.,  JP 916-8505
Product CodeHQZ  
CFR Regulation Number886.5842 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-13
Decision Date1993-09-09

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