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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 K903202
Device Name TOY SUNGLASSES
Applicant
Creative Design
Suite 321a,
Benjamin Fox Pavilion
Jenkintown,  PA  19046
Applicant Contact MARVIN GREENBERG
Correspondent
Creative Design
Suite 321a,
Benjamin Fox Pavilion
Jenkintown,  PA  19046
Correspondent Contact MARVIN GREENBERG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/20/1990
Decision Date 08/28/1990
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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