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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 K934659
Device Name SUNGLASS
Applicant
South American Plastic Manufactory Co. , Ltd.
7/F, Kam Mow Industrial Bldg.
44 Belcher'S St.
West Point, Hong Kong,  HK
Applicant Contact SAMSON CHAN HUNG SING
Correspondent
South American Plastic Manufactory Co. , Ltd.
7/F, Kam Mow Industrial Bldg.
44 Belcher'S St.
West Point, Hong Kong,  HK
Correspondent Contact SAMSON CHAN HUNG SING
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/21/1993
Decision Date 05/17/1994
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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