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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 K940250
Device Name NEW EYES EYEGLASS FRAME
Applicant
Sunrise International Business
617 Manomet Ct.
Schaumburg,  IL  60173
Applicant Contact DAVID H XU, PH,D.
Correspondent
Sunrise International Business
617 Manomet Ct.
Schaumburg,  IL  60173
Correspondent Contact DAVID H XU, PH,D.
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/21/1994
Decision Date 04/19/1994
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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