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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 K971875
Device Name OPTIM-EYES 450
Applicant
Taylor/Fox Enterprises, LLC
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact ELIZABETH S CROCKETT
Correspondent
Taylor/Fox Enterprises, LLC
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact ELIZABETH S CROCKETT
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/20/1997
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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