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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 K941267
Device Name NON-PRESCRIPTION SUNGLASSES
Applicant
Topstar Trading , Ltd.
9/F, # 163, Hang On Bldg.
Sai Yeung Chai St. N.
Kowloon Hong Kong,  HK
Applicant Contact DICK LIAO
Correspondent
Topstar Trading , Ltd.
9/F, # 163, Hang On Bldg.
Sai Yeung Chai St. N.
Kowloon Hong Kong,  HK
Correspondent Contact DICK LIAO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/16/1994
Decision Date 02/17/1995
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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