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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 K953092
Device Name FOSTER GRANT NON PRESCRIPTION SUNGLASSES
Applicant
Foster Grant Group
901 Main St., Suite 4300
Dallas,  TX  75202
Applicant Contact ANDREW G HALPERN
Correspondent
Foster Grant Group
901 Main St., Suite 4300
Dallas,  TX  75202
Correspondent Contact ANDREW G HALPERN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/03/1995
Decision Date 07/19/1995
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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