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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 K945680
Device Name METZLER, ALPINA, MENRAD, POLICE, L. BIAGIOTTI, CFF, R. LAUREN, POLO, NEOMETAL, L'AMY, NEOSTYLE ETC.
Applicant
Solex Marketing, Inc.
13616 SE 7th St.
Bellevue,  WA  98005
Applicant Contact ALEXANDER D NALBANTU
Correspondent
Solex Marketing, Inc.
13616 SE 7th St.
Bellevue,  WA  98005
Correspondent Contact ALEXANDER D NALBANTU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/21/1994
Decision Date 02/07/1995
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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