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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 K974511
Device Name SUNGLASSES
Applicant
Sun World Intl., Inc.
316 Roosevelt Ave.
Franklin Square,  NY  11010
Applicant Contact LILLIAN YEN
Correspondent
Sun World Intl., Inc.
316 Roosevelt Ave.
Franklin Square,  NY  11010
Correspondent Contact LILLIAN YEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/01/1997
Decision Date 01/12/1998
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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