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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 K863555
Device Name BREMI BEAUTY BRONZE
Applicant
Handelsonderneming Bremi B.V.
Postbus 47
5527 Zg Hapert
Holland,  NL
Applicant Contact BREKELMANS
Correspondent
Handelsonderneming Bremi B.V.
Postbus 47
5527 Zg Hapert
Holland,  NL
Correspondent Contact BREKELMANS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/12/1986
Decision Date 10/02/1986
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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