SUNGLASSES

Sunglasses (non-prescription Including Photosensitive)

KAI TAI OPTICAL MFG. CO. LTD.

The following data is part of a premarket notification filed by Kai Tai Optical Mfg. Co. Ltd. with the FDA for Sunglasses.

Pre-market Notification Details

Device IDK930659
510k NumberK930659
Device Name:SUNGLASSES
ClassificationSunglasses (non-prescription Including Photosensitive)
Applicant KAI TAI OPTICAL MFG. CO. LTD. 345 DES VOUEX ROAD, WEST CHEUNG KA INDU. BLDG. 16TH FL. Flat B, Hong Kong,  HK
ContactThomas Lau
CorrespondentThomas Lau
KAI TAI OPTICAL MFG. CO. LTD. 345 DES VOUEX ROAD, WEST CHEUNG KA INDU. BLDG. 16TH FL. Flat B, Hong Kong,  HK
Product CodeHQY  
CFR Regulation Number886.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-09
Decision Date1994-02-16

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