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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 K974179
Device Name NON-PRESCRIPTION SUNGLASSES
Applicant
Taipan Optical Company , Ltd.
18 Tak Fung St., Suite 1702
One Harbourfront 17th Floor
Kowloon,  HK
Applicant Contact HENRY HSU
Correspondent
Taipan Optical Company , Ltd.
18 Tak Fung St., Suite 1702
One Harbourfront 17th Floor
Kowloon,  HK
Correspondent Contact HENRY HSU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/06/1997
Decision Date 12/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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