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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 K943377
Device Name SUNGLASSES (NON-PRESCRIPTION)
Applicant
Carol Wright Sales
70 Seaview Ave., P.O. Box
10250
Stamford,  CT  06904
Applicant Contact DESIREE M ELLIS-VIOLETTE
Correspondent
Carol Wright Sales
70 Seaview Ave., P.O. Box
10250
Stamford,  CT  06904
Correspondent Contact DESIREE M ELLIS-VIOLETTE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/13/1994
Decision Date 08/17/1994
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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