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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 K950391
Device Name NON-PRESCRIPTION SUNGLASSES
Applicant
Aceway Sunglasses Corp.
17753 Nearbank Dr.
Rowland Heights,  CA  91748
Applicant Contact LING-JU LIN
Correspondent
Aceway Sunglasses Corp.
17753 Nearbank Dr.
Rowland Heights,  CA  91748
Correspondent Contact LING-JU LIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/01/1995
Decision Date 03/01/1995
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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