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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 K945817
Device Name SUNGLASSES
Applicant
WALMART STORES
702 S.W. 8TH ST. - DEPT. 8023
BENTONVILLE,  AR  72716 -8023
Applicant Contact K EARNEY
Correspondent
WALMART STORES
702 S.W. 8TH ST. - DEPT. 8023
BENTONVILLE,  AR  72716 -8023
Correspondent Contact K EARNEY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/28/1994
Decision Date 01/05/1995
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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