SPECTACLE FRAMES

Frame, Spectacle

SUNNY UNION INDUSTRIAL CO., LTD.

The following data is part of a premarket notification filed by Sunny Union Industrial Co., Ltd. with the FDA for Spectacle Frames.

Pre-market Notification Details

Device IDK943442
510k NumberK943442
Device Name:SPECTACLE FRAMES
ClassificationFrame, Spectacle
Applicant SUNNY UNION INDUSTRIAL CO., LTD. P.O. BOX 53-1105, 4F, NO. 39 LANE 131 YEN - CHI STREET Taipei,  TW
ContactTeddy Wang
CorrespondentTeddy Wang
SUNNY UNION INDUSTRIAL CO., LTD. P.O. BOX 53-1105, 4F, NO. 39 LANE 131 YEN - CHI STREET Taipei,  TW
Product CodeHQZ  
CFR Regulation Number886.5842 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-18
Decision Date1994-08-02

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