SUNGLASSES

Sunglasses (non-prescription Including Photosensitive)

GREAT FIELD INDUSTRIES CO., LTD.

The following data is part of a premarket notification filed by Great Field Industries Co., Ltd. with the FDA for Sunglasses.

Pre-market Notification Details

Device IDK944568
510k NumberK944568
Device Name:SUNGLASSES
ClassificationSunglasses (non-prescription Including Photosensitive)
Applicant GREAT FIELD INDUSTRIES CO., LTD. 1 FL., NO.109, MIN CHUAN RD. Hsin Tien City, Taipei Hsien,  TW
ContactJerry Chao
CorrespondentJerry Chao
GREAT FIELD INDUSTRIES CO., LTD. 1 FL., NO.109, MIN CHUAN RD. Hsin Tien City, Taipei Hsien,  TW
Product CodeHQY  
CFR Regulation Number886.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-19
Decision Date1995-01-09

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