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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 K803308
Device Name FASHION SUNGLASSES
Applicant
Grand Imperial, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Grand Imperial, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/30/1980
Decision Date 04/03/1981
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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