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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K930561
Device Name SOLSTAR BRILLENMODE SPECTACLE FRAMES
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 Number886.5842
Classification Product Code
HQZ  
Date Received02/03/1993
Decision Date 05/03/1993
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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