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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 K974441
Device Name SUNGLASSES
Applicant
Hip Shing Fat Co., Ltd.
1829-1832 Star House, Tst
Kowloon,  HK
Applicant Contact PETER K C. LEE
Correspondent
Hip Shing Fat Co., Ltd.
1829-1832 Star House, Tst
Kowloon,  HK
Correspondent Contact PETER K C. LEE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/25/1997
Decision Date 01/09/1998
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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