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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 K904281
Device Name NONPRESCRIPTION SUNGLASSES
Applicant
Jennie G. Sales Co., Inc.
3770 W. Pratt Ave.
Lincolnwood,  IL  60645
Applicant Contact SEYMOUR GOLDSTEIN
Correspondent
Jennie G. Sales Co., Inc.
3770 W. Pratt Ave.
Lincolnwood,  IL  60645
Correspondent Contact SEYMOUR GOLDSTEIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/17/1990
Decision Date 11/21/1990
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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