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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 K902868
Device Name RUBBER SUNGLASSES
Applicant
PREMIUM SOURCE MERCHANDISING
9935 SANTA MONICA BLVD.
SUITE 102
BEVERLY HILLS,  CA  90212
Applicant Contact THRALL, JR.
Correspondent
PREMIUM SOURCE MERCHANDISING
9935 SANTA MONICA BLVD.
SUITE 102
BEVERLY HILLS,  CA  90212
Correspondent Contact THRALL, JR.
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/29/1990
Decision Date 08/08/1990
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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