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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 K932814
Device Name NON-PRESCRIPTION SUGLASSES
Applicant
Sun Style Intl. Corp.
393 Fifth Ave.
New York,  NY  10016
Applicant Contact EMILY LAM
Correspondent
Sun Style Intl. Corp.
393 Fifth Ave.
New York,  NY  10016
Correspondent Contact EMILY LAM
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/09/1993
Decision Date 09/20/1993
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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