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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 K941638
Device Name SUNGLASSES
Applicant
Sun Coast Merchandise Corp.
6405 Randolph St.
Commerce,  CA  90040
Applicant Contact VIDYA BHAVNANI
Correspondent
Sun Coast Merchandise Corp.
6405 Randolph St.
Commerce,  CA  90040
Correspondent Contact VIDYA BHAVNANI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/04/1994
Decision Date 05/17/1994
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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