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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 K926564
Device Name OPTICAL FRAMES AND SUNGLASSES
Applicant
Solstar Produktions GmbH
33 Koschatsrasse
Spittal/Drau
Austria,  AT
Applicant Contact DIETER HOSSL
Correspondent
Solstar Produktions GmbH
33 Koschatsrasse
Spittal/Drau
Austria,  AT
Correspondent Contact DIETER HOSSL
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received12/31/1992
Decision Date 07/27/1994
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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