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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 K910125
Device Name SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA)
Applicant
The Limited Stores, Inc.
C/O Grunfeld/Desiderio/Lebowit
Silverman, 12 E. 49th St.
New York,  NY  10017
Applicant Contact SCOTT A COHN
Correspondent
The Limited Stores, Inc.
C/O Grunfeld/Desiderio/Lebowit
Silverman, 12 E. 49th St.
New York,  NY  10017
Correspondent Contact SCOTT A COHN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/07/1991
Decision Date 03/14/1991
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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