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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 K901571
Device Name SUNGLASSES STYLE #(CM-1989)
Applicant
Zaks Stores, Inc.
14280 Gillis Rd.
Dallas,  TX  75244
Applicant Contact JACKIE KENDRO
Correspondent
Zaks Stores, Inc.
14280 Gillis Rd.
Dallas,  TX  75244
Correspondent Contact JACKIE KENDRO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/03/1990
Decision Date 06/20/1990
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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