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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 K902519
Device Name EYE SPY SUNGLASSES
Applicant
E. M. Intl. Products , Ltd.
49 W. 37th St.
New York,  NY  10018
Applicant Contact ELLIOT MIZRAHI
Correspondent
E. M. Intl. Products , Ltd.
49 W. 37th St.
New York,  NY  10018
Correspondent Contact ELLIOT MIZRAHI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/06/1990
Decision Date 09/24/1990
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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