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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 K893986
Device Name NEW WEST SUNGLASSES
Applicant
New West Promotions
310 Golden Sheore Suite 240
Long Beach,  CA  90802
Applicant Contact FRANK GINIPRO
Correspondent
New West Promotions
310 Golden Sheore Suite 240
Long Beach,  CA  90802
Correspondent Contact FRANK GINIPRO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/05/1989
Decision Date 07/25/1989
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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