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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 K972014
Device Name SUNGLASSES (NON-PRESCRIPTION)
Applicant
Tamfort, Ltd.
420 Fifth Ave.
New York,  NY  10018
Applicant Contact CAROLYN Z SLOVIS
Correspondent
Tamfort, Ltd.
420 Fifth Ave.
New York,  NY  10018
Correspondent Contact CAROLYN Z SLOVIS
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/30/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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