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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 K951209
Device Name SUNGLASSES
Applicant
Mainland Wholesale
11526 Burbank Blvd., #1
North Hollywood,  CA  91601
Applicant Contact SHUNRUO XUAN
Correspondent
Mainland Wholesale
11526 Burbank Blvd., #1
North Hollywood,  CA  91601
Correspondent Contact SHUNRUO XUAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/17/1995
Decision Date 04/04/1995
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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