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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 K935264
Device Name CHILDREN'S SUNGLASSES
Applicant
Agglo Corp. , Ltd.
6-6a Hart Ave., 3rd Floor
Hong Kong,  HK
Applicant Contact Y C LEE
Correspondent
Agglo Corp. , Ltd.
6-6a Hart Ave., 3rd Floor
Hong Kong,  HK
Correspondent Contact Y C LEE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/02/1993
Decision Date 08/10/1994
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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