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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 K903487
Device Name SOLARSHIELDS ENCORE
Applicant
Dioptics
51 Zaca Ln.
San Luis Obispo,  CA  93401
Applicant Contact LEE LANGLEY
Correspondent
Dioptics
51 Zaca Ln.
San Luis Obispo,  CA  93401
Correspondent Contact LEE LANGLEY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/31/1990
Decision Date 11/05/1990
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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