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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 K971707
Device Name SUNGLASSES (NON-PRESCRIPTION)
Applicant
Niko Sunglasses Corp.
401 S. Los Angeles St., #2
Los Angeles,  CA  90013
Applicant Contact FU-HSING LIU
Correspondent
Niko Sunglasses Corp.
401 S. Los Angeles St., #2
Los Angeles,  CA  90013
Correspondent Contact FU-HSING LIU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/06/1997
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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