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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K843902
Device Name SOLAR-GOLD UV-A BY EOS
Applicant
Eos-Werke, Gunther GmbH
6349 Driedorf
West Germany,  DE
Applicant Contact GUNTER GMBH-MADEMUHL
Correspondent
Eos-Werke, Gunther GmbH
6349 Driedorf
West Germany,  DE
Correspondent Contact GUNTER GMBH-MADEMUHL
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/03/1984
Decision Date 11/08/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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