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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 K925171
Device Name FREE SUN PRO DESIGN 3000 AND 3800
Applicant
Free Sun Prod. AB
Rasbo Hammarby 75596
Uppsala, Sweden,  SE
Applicant Contact ERIK EKH
Correspondent
Free Sun Prod. AB
Rasbo Hammarby 75596
Uppsala, Sweden,  SE
Correspondent Contact ERIK EKH
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/14/1992
Decision Date 12/29/1992
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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