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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 K953473
Device Name SUNGLASSES (NON-PRESCRIPTION)
Applicant
Cbi Dist.
1501 Michael Dr.
Wooddale,  IL  60191
Applicant Contact JOANNE BALICE
Correspondent
Cbi Dist.
1501 Michael Dr.
Wooddale,  IL  60191
Correspondent Contact JOANNE BALICE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/24/1995
Decision Date 08/07/1995
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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