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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 K935231
Device Name TALE SPIN SUNSHADES
Applicant
Equity Marketing, Inc.
156 Fifth Ave.
New York,  NY  10010
Applicant Contact CRISTOPHER A MOZOLEWSKI
Correspondent
Equity Marketing, Inc.
156 Fifth Ave.
New York,  NY  10010
Correspondent Contact CRISTOPHER A MOZOLEWSKI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/01/1993
Decision Date 01/25/1994
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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