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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 K860859
Device Name UVA SUN SYSTEMS
Applicant
Bremi
Postbus 47
5527 Zg Hapert
Holland,  NL
Applicant Contact BREKELMANS
Correspondent
Bremi
Postbus 47
5527 Zg Hapert
Holland,  NL
Correspondent Contact BREKELMANS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received03/07/1986
Decision Date 03/28/1986
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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