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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 K951438
Device Name BENSON AND ASHLEY
Applicant
Benson & Ashley, Inc.
3 Victoria Sq.
Rehoboth,  DE  19971
Applicant Contact ALISON BLYTH
Correspondent
Benson & Ashley, Inc.
3 Victoria Sq.
Rehoboth,  DE  19971
Correspondent Contact ALISON BLYTH
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/27/1995
Decision Date 05/10/1995
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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