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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 K964943
Device Name SUNGLASSES (NON-PRESCRIPTION)
Applicant
Micron Eyewear Manufactory Co., Ltd.
Unit 20, 5/F, Well Fung Ind.
Ctr., 68 Ta Chuen Ping St.,
Kwai Chung, N.T.,  HK
Applicant Contact CHRIS WONG SIU HING
Correspondent
Micron Eyewear Manufactory Co., Ltd.
Unit 20, 5/F, Well Fung Ind.
Ctr., 68 Ta Chuen Ping St.,
Kwai Chung, N.T.,  HK
Correspondent Contact CHRIS WONG SIU HING
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/10/1996
Decision Date 02/25/1997
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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