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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 K945925
Device Name EYEWEAR/SPECTACLES
Applicant
Kovision Mfg., Ltd.
Rm. 908/Floor, Wu Sang House
655m Hathan Rd., Kowloon
Hong Kong,  CN
Applicant Contact IVY KO NGAN KUEN
Correspondent
Kovision Mfg., Ltd.
Rm. 908/Floor, Wu Sang House
655m Hathan Rd., Kowloon
Hong Kong,  CN
Correspondent Contact IVY KO NGAN KUEN
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received12/05/1994
Decision Date 01/17/1995
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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