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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K930659
Device Name SUNGLASSES
Applicant
Kai Tai Optical Mfg. Co. , Ltd.
345 Des Vouex Rd., W.
Cheung Ka Indu. Bldg. 16th Floor
Flat B, Hong Kong,  HK
Applicant Contact THOMAS LAU
Correspondent
Kai Tai Optical Mfg. Co. , Ltd.
345 Des Vouex Rd., W.
Cheung Ka Indu. Bldg. 16th Floor
Flat B, Hong Kong,  HK
Correspondent Contact THOMAS LAU
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received02/09/1993
Decision Date 02/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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